EA040869B1 - PHARMACEUTICAL COMPOSITION FOR TREATMENT OF INFLAMMATORY DISEASES - Google Patents

Description

Cross-reference to related applications

This application claims priority under 35 U.S.C. 119(e) of US Patent Application No. 61/295387, filed January 10, 2010, and US Patent Application No. 61/422059, filed December 10, 2010, which are incorporated herein by reference.

State of the art

Interleukin-17 (IL-17A) is an inflammatory cytokine originally identified as a transcript selectively expressed by activated T cells. IL-17A and IL-17F bind and activate IL-17RA. IL-17RA has been shown to be important in the regulation of the immune response. Activation of IL-17RA leads to the production of cytokines, chemokines, growth factors and other proteins that contribute to the symptoms and/or pathology of numerous diseases. IL-17A is an inflammatory cytokine that induces the production of cytokines and other mediators leading to disease and physiological effects such as inflammation, cartilage degradation and bone resorption. IL-17A may be involved in a number of inflammatory conditions including arthritis (rheumatoid arthritis), psoriasis, inflammatory bowel disease, multiple sclerosis and asthma. (Li et al., 2004, Huazhong Univ. Sci. Technolog. Med. Sci. 24:294-296; Fujino et al., 2003, Gut. 52:65-70; Kauffman et al., 2004, J. Invest Dermatol 123:1037-1044; Mannon et al., 2004, N. Engl. J. Med. 351:2069-2079; Matusevicius et al., 1999, Mult Scler, 5, 101-104; Linden et al. , Eur Respir J. 2000 May;15(5):973-7; Molet et al., 2001, J. Allergy Clin. Immunol. 108:430-438). Recent studies have suggested that IL-17F is involved in the induction of inflammatory responses (Oda et al., 2006, American J. Resp. Crit. Care Medicine, Jan. 15, 2006; Numasaki et al., 2004, Immunol Lett. 95 :97-104).

The IL-17 receptor A (IL-17RA) has been shown to bind and be activated by IL-17A and IL-17F. Five additional IL-17-like ligands (IL-17B-IL-17F) and four additional IL-17RA-like receptors (IL-17RB-IL-17RE) have been identified (Rolls and Linden, 2004, Immunity, 21:467476; Gaffen, 2009, Nat Rev Immunol 8:556-568). The IL-17 receptor C (IL-17RC) has been shown to bind and be activated by IL-17A and IL-17F. IL-17RA and IL-17RC form a functional heteromeric receptor complex (Toy et al., 2006, J. Immunol. 177:36-39; McAllister et al., 2005, J. Immunol. 175:404412). In addition, the IL-17 receptor B (IL-17RB) has also been shown to require IL-17RA for IL-25 mediated activity (Rickel, et al., 2008, J. Immunol. 181:4299-4310) and IL- 17RD interacts with IL-17RA to mediate IL-17 signaling (Rong, et al., 2009, Cell Research, 19:208-215).

Description of figures

Fig. 1. Graph showing the relationship between viscosity and shear rate for various AM-14 formulations. Various excipients were evaluated in 10 mM glutamate buffer, pH 4.5, with the concentration of AM-14 kept constant at approximately 180 mg/ml.

Fig. 2. Graph illustrating the relationship between viscosity and shear rate for various AM-14 formulations. Various excipients were evaluated in 10 mM glutamate buffer, pH 5.5, with AM-14 held constant at approximately 180 mg/ml.

Fig. 3. Graph showing the viscosity of AM-14 at various protein concentrations.

Fig. 4. Graph showing the relationship between the viscosity of the AM-14 formulation at 200 mg/mL and pH variation.

Fig. 5. Graph showing the mean percentage occupancy of the IL-17 receptor as a function of time in healthy volunteers administered doses of 21-700 mg of AM-14.

Fig. 6. Graph showing the mean percentage occupancy of the IL-17 receptor as a function of time in psoriasis patients treated with AM-14 doses of 140, 210 and 700 mg.

Fig. 7. Graph showing the mean percentage occupancy of the IL-17 receptor as a function of time in rheumatoid arthritis following 50-210 mg doses of AM-14.

Fig. 8. Graph showing the monotonically increasing relationship between pEC ₅₀ shift measured in whole blood stimulation assay and circulating AM-14 concentration as measured in pharmacokinetic assay. The AM-14 concentration is on the x-axis and the pEC ₅₀ shift is on the y-axis.

Fig. 9. Graphical representation of the predicted mean pharmacokinetic profiles of AM-14 based on a simulation of a single dose study.

Fig. 10. Schematic of the PK-PD model used in some forms of analysis. The syringe indicates the points of injection of doses: bolus in the depot compartment (s/c); infusion in the central compartment (IV) or initiation of the placebo effect. Inflammation (as measured by PASI) is presented in an inflammation compartment with endogenous rates of synthesis (ksyn) and degradation (kdeg). Drug concentrations in the effect compartment act to decrease ksyn and thereby reduce inflammation. The placebo effect is modeled as a hypothetical compartment with its own kinetics. The placebo effect works by increasing kdeg and thereby reducing inflammation.

Fig. 11. Depiction of model predicted PASI (as percent of baseline) versus mean (SD) of detected PASI data (as percent of baseline per group) over time after a single dose of AM-14 or placebo.

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Fig. 12. Plot of PASI predicted response over time for different dose scenarios (including placebo).

Fig. 13. Graphical representation of the predicted median percentage improvement in PASI (dose-response curve) at 12 weeks for AM-14, with 90% confidence interval highlighted by the shaded area; for various dose levels, each administered sc at weeks 0, 1, 2, 4, 6, 8 and 10.

Fig. 14. Graph showing changes in epidermal thickness over time in AM-14 treated individuals (solid symbols) versus placebo (open circles). The introduction of AM-14 resulted in a significant reduction in the thickness of the epidermis in individuals with psoriasis compared with placebo.

Fig. 15. Graph showing changes in keratin-16 (KRT16) levels over time in AM-14 treated individuals (solid symbols) versus placebo (open circles). The introduction of AM-14 resulted in a significant decrease in the amount of mRNA KRT16 in individuals with psoriasis compared with placebo.

Fig. 16. Graph showing changes in the amount of Ki67 over time in AM-14 treated individuals (solid symbols) compared to placebo (open circles). AM-14 resulted in a significant reduction in Ki67 in individuals with psoriasis compared to placebo.

Detailed description

It is understood that any and all of the various features of the embodiments provided herein are described in separate paragraphs and are further combined in a particular embodiment, or the selection of a particular embodiment from a list of embodiments does not provide an added or new entity. Applicants affirmatively declare that all such combinations are specifically contemplated and specifically covered by this description.

IL-17 A receptor.

The IL-17 or IL-17RA A receptor (used interchangeably herein, as well as IL-17 receptor and IL-17R; all refer to the same receptor) is a cell surface receptor known in the art (see eg Yao, et al., 1997, Cytokine, Vol 9, No. 11:794-800). Cloning, characterization of IL-17RA are described, for example, in US patent No. 6072033, which is incorporated herein by reference in its entirety. IL-17RA binds at least IL-17A and/or IL-17F and is activated by IL-17A and/or IL-17F or other IL-17 ligands, as well as heteromeric forms of one or more IL-17 ligands, such as, but not limited to, IL-17A/IL-17F heteromers.

Biopharmaceutical formulations of anti-IL-17RA antibody.

Aspects of the present invention relate to biopharmaceutical formulations (also referred to herein simply as formulation) comprising the AM-14 antibody, as variously defined herein. AM-14 is described in detail in WO 2008/054603, USSN 11/906094, USPN7786234, USPN 7833527 and USPN 7767206, which are incorporated herein by reference in their entirety. AM-14 binds specifically to human IL-17RA and inhibits the biological activity of IL-17A, IL-17F and IL-17A/IL-17F heterodimers and/or activation of IL-17RA and the heteromeric complex of IL-17RA and IL-17RC ( IL-17 C receptor). AM-14 also has the unique property of inhibiting IL-17RB (IL-17 receptor B) activation via its IL-25 ligand, without being bound by theory, presumably by influencing the heteromeric receptor complex containing IL-17RA and IL-17RB. The IL-17RA-RB complex and the use of AM-14 to inhibit the biological activity of IL-25 are described in PCT/US2009/001085, incorporated herein by reference in its entirety.

AM-14 contains a heavy chain sequence containing SEQ ID NO: 1 (or, alternatively, a heavy chain sequence containing SEQ ID NO: 12 in which the COOH-terminal Lys is removed from SEQ ID NO: 1), and a light chain sequence, containing SEQ ID NO: 2, or its binding human IL-17RA fragment. AM-14 contains a heavy chain variable region sequence comprising SEQ ID NO: 3 and a light chain variable region sequence comprising SEQ ID NO: 4, or a human IL-17RA binding fragment thereof, wherein said AM-14 antibody binds IL-17RA person. AM-14 contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 6 (or alternatively, a heavy chain CDR2 containing SEQ ID NO: 7), a heavy chain CDR3 containing SEQ ID NO: : 8, a light chain CDR1 comprising SEQ ID NO: 9, a light chain CDR2 comprising SEQ ID NO: 10, and a light chain CDR3 comprising SEQ ID NO: 11, or a human IL-17RA binding fragment thereof, wherein said antibody is AM -14 binds human IL-17RA.

As used herein, the term biopharmaceutical means a macromolecule, such as a polypeptide, nucleic acid, carbohydrate or lipid, or a structural element thereof, which is intended to be used as a pharmaceutical agent, which in this case is the AM-14 antibody. A biopharmaceutical formulation refers to a pharmaceutically acceptable carrier that is compatible with the biopharmaceutical molecule and is safe and non-toxic when administered to a human.

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The singular form refers to one or more, for example, it should be understood that an immunoglobulin molecule corresponds to one or more immunoglobulin molecules. As such, the singular form, the terms one or more, and at least one may be used interchangeably herein.

It is clear that when describing a range of values, the described characteristic may be a single value that is in this range. For example, a pH of about 4 to about 6 may be, but is not limited to, pH 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7 , 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6 ,0 etc. and any value in between such values. In addition, a pH of about 4 to about 6 should not be construed as indicating that the pH of the composition in question varies by 2 pH units in the range of 4 to 6 during storage, but rather that the value can be selected from this range for the pH of the solution, and the pH remains buffered at approximately this pH level.

A formulation containing a buffer solution and AM-14 is provided. The buffer solution may contain a buffer based on glutamic acid or acetic acid. The buffer solution contains a glutamic acid buffer. Also provided in the description is a method for preparing the formulation, methods for treating the condition using the included AM-14, and a kit containing the components of the formulation.

A high value achievement for formulation AM-14 (ie AM-14 biopharmaceutical formulations) is that high concentrations of AM-14 in solution have been achieved. Thus, embodiments include highly concentrated formulations of AM-14. Formulations with a high concentration of AM-14 are desirable as this allows for lower volume administration and/or fewer administrations and therefore less inconvenience to the patient.

An additional achievement of high value is that AM-14 formulations have a relatively low viscosity at high protein concentrations. AM-14 formulations having a lower viscosity are highly desirable as it facilitates production (such as but not limited to processing, filtration and filling), use of standard syringes and needle configurations (suitable for the given route of administration), adaptability to art-known autoinjection and microinfusion devices, ease of insertion, and reduced shear forces when AM-14 is administered. An additional benefit of the lower viscosity of AM-14 formulations is less patient discomfort upon administration.

The next high value achievement in the prior art is that the AM-14 formulations described herein having a high concentration of AM-14 (i.e. >100 mg/mL) are surprisingly stable as described in stability studies in example 1.

In addition, it was surprisingly discovered that glutamate formulations with 10 mM glutamate did not induce unacceptable burning/pain when injected subcutaneously as described in Example 5.

Embodiments of AM-14 formulations include the AM-14 biopharmaceutical formulation having a concentration range of AM-14 in solution: 60-250, 60-240, 60-230, 60-220, 60-210, 60-200, 60-190, 60180, 60-170, 60-160, 60-150, 60-140, 60-130, 60-120, 60-110, 60-100, 70-250, 70-240, 70-230, 70-220, 70-210, 70-200, 70-190, 70-180, 70-170, 70-160, 70-150, 70-140, 70-130, 70-120, 70-110, 70-100, 80 -250,

80-240, 80-230, 80-220, 80-210, 80-200, 80-190, 80-180, 80-170, 80-160, 80-150, 80-140, 80-130, 80- 120

80-110, 80-100, 90-250, 90-240, 90-230, 90-220, 90-210, 90-200, 90-190, 90-180, 90-170, 90-160, 90- 150,

90-140, 90-130, 90-120, 90-110, 90-100, 100-250, 100-240, 100-230, 100-220, 100-210, 100-200, 100-190,

100-180, 100-170, 100-160, 100-150, 100-140, 100-130, 100-120, 100-110, 110-250, 110-240, 110-230,

110-220, 110-210, 110-200, 110-190, 110-180, 110-170, 110-160, 110-150, 110-140, 110-130, 110-120,

120-250, 120-240, 120-230, 120-220, 120-210, 120-200, 120-190, 120-180, 120-170, 120-160, 120-150,

120-140, 120-130, 130-250, 130-240, 130-230, 130-220, 130-210, 130-200, 130-190, 130-180, 130-170,

130-160, 130-150, 130-140, 140-250, 140-240, 140-230, 140-220, 140-210, 140-200, 140-190, 140-180,

140-170, 140-160, 140-150, 150-250, 150-240, 150-230, 150-220, 150-210, 150-200, 150-190, 150-180,

150-170, 150-160, 160-250, 160-240, 160-230, 160-220, 160-210, 160-200, 160-190, 160-180, 160-170,

180-250, 180-240, 180-230, 180-220, 180-210, 180-200, 180-190, 190-250, 190-240, 190-230, 190-220,

190-210, 190-200, 200-250, 200-240, 200-230, 200-220, 200-210, 210-250, 210-240, 210-230, 210-220,

220-250, 220-240, 220-230, 230-250, 230-240 or 240-250 mg/ml.

Embodiments of AM-14 formulations include an AM-14 biopharmaceutical formulation having a concentration of at least

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70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82,

83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98,

99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111,

112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123,124,

125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136,137,

138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149,150,

151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162,163,

164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175,176,

177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188.189,

190, 191, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201.202,

203, 204, 205, 206, 207, 208, 209, 210, 211, 212, 213, 214,215,

216, 217, 218, 219, 220, 221, 222, 223, 224, 225, 226, 227,228,

229, 230, 231, 232, 233, 234, 235, 236, 237, 238, 239, 240,241,

242, 243, 244, 245, 246, 247, 248, 249 or 250 mg/ml.

Embodiments of AM-14 formulations include AM-14 biopharmaceutical formulation having a concentration of 100-150 mg/mL±0.01-5%. Embodiments of AM-14 formulations include AM-14 biopharmaceutical formulation having a concentration of 140 mg/mL±0.01-5%.

Embodiments of AM-14 formulations include an acetic acid or glutamic acid buffer, wherein the concentration of the acetic acid or glutamic acid buffer is from about 5 to 30±0.2 mM, including 5±0.2, 6±0.2 , 7±0.2, 8±0.2, 9±0.2, 10±0.2, 11±0.2, 12±0.2, 13±0.2, 14±0.2, 15 ±0.2, 16±0.2, 17±0.2, 18±0.2, 19±0.2, 20±0.2, 21±0.2, 22±0.2, 23±0 .2, 24±0.2, 25±0.2, 26±0.2, 27±0.2, 28±0.2, 29±0.2 or 30±0.2 mM. Embodiments of AM-14 formulations include a glutamic acid buffer wherein the concentration of glutamic acid buffer is 10±0.2 mM.

As used in the present invention, the term acetic acid buffer means a buffer containing acetic acid. The buffer may be derived from an acetate salt, such as sodium acetate. You can use other salts, such as potassium, ammonium, calcium or magnesium salts of acetate. Acetic acid buffer and acetate buffer are used interchangeably.

As used in the present invention, the term glutamic acid buffer means a buffer containing glutamic acid. The buffer may be made from a glutamate salt, such as monosodium glutamate. Other salts may be used, such as potassium, ammonium, calcium or magnesium salts of glutamate. Glutamic acid buffer and glutamate buffer are used interchangeably.

In other embodiments, glutamic acid and/or acetic acid buffers may be used in combination with proline as an excipient (including L-proline).

Embodiments of AM-14 formulations include an acetic acid or glutamic acid buffer having a pH of 4.5 to 5.5±0.2 or a range of 4.8 to 5.2±0.2, including pH 4 .6±0.2, 4.7±0.2, 4.8±0.2, 4.9±0.2, 5.0±0.2, 5.1±0.2, 5.2 ±0.2, 5.3±0.2, 5.4±0.2 and 5.5±0.2. Embodiments of AM-14 formulations include a glutamic acid buffer having a pH of 4.8±0.2.

As used in the present invention, the term excipient means a therapeutically inactive substance. Excipients can be incorporated into a biopharmaceutical formulation for a wide variety of purposes, including, for example, as a diluent, carrier, buffer, stabilizer, tonicity agent, excipient, surfactant, cryoprotectant, lyoprotectant, antioxidant, metal ion source, chelating agent. agent and/or preservative. Optimal excipients are also chosen to enhance or provide stabilization in relation to the mode of administration of the aqueous biopharmaceutical composition of the invention. For example, parenteral routes such as intravenous (IV), subcutaneous (SC), or intramuscular (IM) administration may be safer and more effective when all components of the formulation are physically and chemically stable during manufacture, storage, and administration. . The excipients illustrated herein for use in a biopharmaceutical formulation exhibit these and other characteristics. Excipients are well known in the art and can be found, for example, in Wang W., Int. J Pharm. 185:129-88 (1999) and Wang W., Int. J Pharm. 203:1-60 (2000).

Excipients include, for example, polyols such as sorbitol or mannitol; sugars such as sucrose, lactose or dextrose; polymers such as polyethylene glycol; salts such as NaCl, KCl or calcium phosphate; amino acids such as glycine, methionine or glutamic acid, surfactants, metal ions, buffer salts such as propionate, acetate or succinate, preservatives and polypeptides such as human serum albumin, as well as saline and water. Dru

- 4 040869 Other excipients suitable either in liquid or lyophilized biopharmaceutical composition according to the invention include, for example, fucose, cellobiose, maltotriose, melibiose, octullose, ribose, xylitol, arginine, histidine, glycine, alanine, methionine, glutamic acid, lysine, imidazole, glycylglycine, mannosylglycerate, Triton X-100, Pluoronic F-127, cellulose, cyclodextrin, dextran (10, 40 and/or 70 kDa), polydextrose, maltodextrin, ficoll, gelatin, hydroxypropyl meth, sodium phosphate, potassium phosphate, ZnCl ₂ , zinc, zinc oxide, sodium citrate, sodium tricitrate, tromethamine, copper, fibronectin, heparin, human serum albumin, protamine, glycerol, glycerol, EDTA, metacresol, benzyl alcohol and phenol. Sugar alcohols, also known as polyols, polyhydric alcohols or polyalcohols, are hydrogenated forms of carbohydrates having a carbonyl group reduced to a primary or secondary hydroxyl group. Polyols can be used to stabilize excipients and/or as isotonicity agents in both liquid and lyophilized formulations. Polyols can protect biopharmaceuticals from both physical and chemical degradation pathways. Preferably, the omitted co-solvents increase the effective surface tension of the solvent at the interface of the protein, whereby the most energetically favorable structural conformations are those with the smallest surface area. Specific examples of sugar alcohols include sorbitol, glycerin, mannitol, xylitol, maltitol, lactitol, erythritol and threitol. Reducing sugars include, for example, sugars with a ketone or aldehyde group and contain a reactive hemiacetal group which allows the sugar to act as a reducing agent. Specific examples of reducing sugars include fructose, glucose, glyceraldehyde, lactose, arabinose, mannose, xylose, ribose, rhamnose, galactose, and maltose. Non-reducing sugars contain an anomeric carbon which is an acetal and is not substantially reactive with amino acids or polypeptides to initiate a Maillard reaction. Specific examples of non-reducing sugars include sucrose, trehalose, sorbose, sucralose, melisitose, and raffinose. Sugar acids include, for example, sugar acids, gluconate and other polyhydroxy sugars and their salts.

Embodiments of AM-14 formulations include sucrose, glycine, proline, glycerol, and/or sorbitol as excipients, which can be included in a concentration range of about 1 to 20±0.2% w/v, or in the range of 5 up to 10±0.2 wt./vol.%, or in the range from 3 to 9±0.2 wt./vol.%, including concentrations of 1±0.2, 2±0.2, 3±0.2 , 4±0.2, 5±0.2, 6±0.2, 7±0.2, 8±0.2, 9±0.2, 10±0.2, 11±0.2, 12 ±0.2, 13±0.2, 14±0.2, 15±0.2, 16±0.2, 17±0.2, 18±0.2, 19±0.2 or 20±0 .2 wt./vol.%.

As used in the context of the invention, the term surfactant means a substance that functions to lower the surface tension of the liquid in which it is dissolved. Surfactants may be included in the biopharmaceutical formulation for various purposes including, for example, preventing or controlling aggregation, particle formation and/or surface adsorption in liquid formulations, or preventing or controlling these phenomena during lyophilization and/or reconstitution in the case of lyophilized formulations. Surfactants include, for example, amphipathic organic compounds which exhibit partial solubility in both organic solvents and aqueous solutions. The main characteristics of surfactants include their ability to reduce the surface tension of water, reduce interfacial tension between oil and water, and form micelles. Surfactants of the invention include non-ionic and ionic surfactants. Surfactants are well known in the art and can be found, for example, in Randolph T.W. and Jones L.S., Surfactant-protein interactions. Pharm Biotechnol. 13:159-75 (2002). Nonionic surfactants include, for example, alkyl poly(ethylene oxide), alkyl polyglucosides such as octyl glucoside and decyl maltoside, fatty alcohols such as cetyl alcohol and oleyl alcohol, MEA cocamide, DEA cocamide, and TEA cocamide. Specific examples of non-ionic surfactants include polysorbates, including, for example, polysorbate 20, polysorbate 28, polysorbate 40, polysorbate 60, polysorbate 65, polysorbate 80, polysorbate 81, polysorbate 85, and the like; poloxamers, including, for example, poloxamer 188, also known as poloxalcol or poly(ethylene oxide)poly(propylene oxide), poloxamer 407 or polyethylene-polypropylene glycol and the like, and polyethylene glycol (PEG). Polysorbate 20 is synonymous with TWEEN 20®, sorbitan monolaurate and polyoxyethylene sorbitan monolaurate. Ionic surfactants include, for example, anionic, cationic, and zwitterionic surfactants. Anionic surfactants include, for example, sulfonate or carboxylate based surfactants such as soaps, fatty acid salts, sodium dodecyl sulfate (SDS), ammonium lauryl sulfate, and other alkyl sulfate salts. Cationic surfactants include, for example, quaternary ammonium surfactants such as cetyltrimethylammonium bromide (CTAB), other alkyltrimethylammonium salts, cetylpyridinium chloride, polyethoxylated tallow amine (POEA), and benzalkonium chloride.

Zwitterionic or amphoteric surfactants include, for example, dodecyl betaine, dodecyl dimethylamine oxide, cocamidopropyl betaine, and cocoamphoglycinate.

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Embodiments of AM-14 formulations include polysorbate 20 (polyoxyethylene sorbitan monolaurate) as a surfactant, which can be included in concentration ranges of about 0.003-1 w/v%, or in the range of about 0.008-0.02 wt. /vol%, including 0.003, 0.004, 0.005, 0.006, 0.007, 0.008, 0.009, 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0, 08, 0.09, 0.1,

0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9 or 1% w/v. Embodiments of AM-14 formulations include glutamate-based buffers containing polysorbate 20 (polyoxyethylene sorbitan monolaurate) as a surfactant at a concentration of approximately 0.005-0.02% w/v. Embodiments of AM-14 formulations include polysorbate 20 (polyoxyethylene sorbitan monolaurate) as a surfactant at a concentration of approximately 0.01% w/v.

The formulation of AM-14 can be formulated to be isotonic with respect to a reference solution or fluid (i.e., blood serum). An isotonic solution has essentially the same amount of solutes in it as the environment, so that it is osmotically stable. When directly compared to a specific solution or liquid, isotonicity or isotonicity is illustratively used herein with reference to human serum (eg, 300 mOsmol/kg). Thus, an isotonic formulation of AM-14 contains a substantially similar concentration of solutes or has a substantially similar osmotic pressure to human blood. Typically, isotonic saline contains approximately the same concentration of solutes as normal saline for humans and many other mammals, which is approximately 0.9% by weight (0.009 g/mL) of salt in aqueous solution (e.g., 0.009 g /ml NaCl). Embodiments of AM-14 formulations include formulations that are isotonic or substantially isotonic and have an osmolarity in the range of about 250 to 400 Osm/L or 275 to 325 Osm/L, including osmolarity

250, 251, 252, 253,

254, 255, 256, 257, 258, 259, 260, 261, 262, 263, 264, 265,266,

267, 268, 269, 270, 271, 272, 273, 274, 275, 276, 277, 278.279,

280, 281, 282, 283, 284, 285, 286, 287, 288, 289, 290, 291,292,

293, 294, 295, 296, 297, 298, 299, 300, 301, 302, 303, 304,305,

306, 307, 308, 309, 310, 311, 312, 313, 314, 315, 316, 317,318,

319, 320, 321, 322, 323, 324, 325, 326, 327, 328, 329, 330,331,

332, 334, 335, 336, 337, 338, 339, 340, 341, 342, 343, 344,345,

346, 347, 348, 349, 350, 351, 352, 353, 354, 355, 356, 357,358,

359, 360, 361, 362, 363, 364, 365, 366, 367, 368, 369, 370,371,

372, 373, 374, 375, 376, 377, 378, 379, 380, 381, 382, 383,384,

385, 386, 387, 388, 389, 390, 391, 392, 393, 394, 395, 396,397,

398, 399 or 400 osm/l.

Embodiments of AM-14 formulations include those described herein that have low viscosity despite having a high concentration of antibody in solution. Embodiments of AM-14 formulations, such as the formulations in the next paragraph, include AM-14 formulations having a viscosity of 4-10 centipoise at 25°C. Embodiments of AM-14 formulations, such as the formulations in the next paragraph, include AM-14 formulations having a viscosity of 5-7 centipoise at 25°C. Embodiments of AM-14 formulations, such as those in the following paragraph, include AM-14 formulations having a viscosity

4.0, 4.1, 4.2,

4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4.5, 5,

5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7.6, 8,

6.9, 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 8.0.8, 1,

8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9, 9.0, 9.1, 9.2, 9.3.9, 4,

9.5, 9.6, 9.7, 9.8, 9.9 or 10 cps at 25 degrees C.

Of course, it is understood that these ranges and values are not limited to the indicated numbers and include other fractional increments (eg, 4.11, 4.12, 4.13, etc.).

Embodiments of AM-14 formulations include, but are not limited to, 100-150mg/mL AM-14 formulated with 5-15mM glutamic acid, 7-9% w/v sucrose, 0.003-0.02 wt./vol.% polysorbate 20, pH 4.5-5.5±0.2. Embodiments of AM-14 formulations include approximately 105 mg/mL AM-14 formulated with 10 mM glutamic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 110 mg/mL AM-14 formulated with 10 mM glutamic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 120 mg/mL AM-14 formulated with 10 mM glutamic

- 6 040869 acid, 8% w/v sucrose, 0.01% w/v polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include approximately 130 mg/mL AM-14 formulated with 10 mM glutamic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 140 mg/mL AM-14 formulated with 10 mM glutamic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 150 mg/mL AM-14 formulated with 10 mM glutamic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2.

Embodiments of AM-14 formulations include, but are not limited to, 100-150mg/mL AM-14 formulated with 5-15mM glutamic acid, 1-3% w/v glycine, 0.003-0.02 wt./vol.% polysorbate 20, pH 4.5-5.5±0.2. Embodiments of AM-14 formulations include approximately 105 mg/mL AM-14 formulated with 10 mM glutamic acid, 2 w/v% glycine, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 110 mg/ml AM-14 formulated with 10 mM glutamic acid, 2% w/v% glycine, 0.01 w/v% polysorbate 20, pH 4, 8±0.2. Embodiments of AM-14 formulations include approximately 120 mg/mL AM-14 formulated with 10 mM glutamic acid, 2 w/v% glycine, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 130 mg/mL AM-14 formulated with 10 mM glutamic acid, 2% w/v% glycine, 0.01 w/v% polysorbate 20, pH 4, 8±0.2. Embodiments of AM-14 formulations include approximately 140 mg/ml AM-14 formulated with 10 mM glutamic acid, 2 w/v% glycine, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 150 mg/ml AM-14 formulated with 10 mM glutamic acid, 2% w/v% glycine, 0.01 w/v% polysorbate 20, pH 4, 8±0.2.

Embodiments of AM-14 formulations include, but are not limited to, 100-150mg/mL AM-14 formulated with 5-15mM glutamic acid, 2-4% w/v proline, 0.003-0.02 wt./vol.% polysorbate 20, pH 4.5-5.5±0.2. Embodiments of AM-14 formulations include approximately 105 mg/ml AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2. Embodiments of AM-14 formulations include approximately 110 mg/ml AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2. Embodiments of AM-14 formulations include approximately 120 mg/ml AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2. Embodiments of AM-14 formulations include approximately 130 mg/mL AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2. Embodiments of AM-14 formulations include approximately 140 mg/mL AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2. Embodiments of AM-14 formulations include 140 mg/ml AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4, 8. Embodiments of AM-14 formulations include approximately 150 mg/ml AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2.

Embodiments of AM-14 formulations include, but are not limited to, 100-150mg/ml AM-14 formulated with 5-15mM acetic acid, 1-3% w/v glycine, 0.003-0.02 wt./vol.% polysorbate 20, pH 4.5-5.5±0.2. Embodiments of AM-14 formulations include approximately 105 mg/mL AM-14 formulated with 10 mM acetic acid, 2 w/v% glycine, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 110 mg/mL AM-14 formulated with 10 mM acetic acid, 2 w/v% glycine, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 120 mg/mL AM-14 formulated with 10 mM acetic acid, 2 w/v% glycine, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 130 mg/ml AM-14 formulated with 10 mM acetic acid, 2 w/v% glycine, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 140 mg/mL AM-14 formulated with 10 mM acetic acid, 2 w/v% glycine, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 150 mg/mL AM-14 formulated with 10 mM acetic acid, 2 w/v% glycine, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2.

Embodiments of AM-14 formulations include, but are not limited to, 100-150mg/mL AM-14 formulated with 5-15mM acetic acid, 2-4% w/v proline, 0.003-0.02 wt./vol.% polysorbate 20, pH 4.5-5.5±0.2. Embodiments of AM-14 formulations include approximately 105 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2. Embodiments of AM-14 formulations include approximately 110 mg/mL AM-14 formulated with 10 mM acetic acid,

- 7 040869% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2. Embodiments of AM-14 formulations include approximately 120 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2. Embodiments of AM-14 formulations include approximately 130 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2. Embodiments of AM-14 formulations include approximately 140 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2. Embodiments of AM-14 formulations include approximately 150 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2.

Embodiments of AM-14 formulations include, but are not limited to, 100-150mg/mL AM-14 formulated with 5-15mM acetic acid, 7-9w/v% sucrose, 0.003-0.02 wt./vol.% polysorbate 20, pH 4.5-5.5±0.2. Embodiments of AM-14 formulations include approximately 105 mg/mL AM-14 formulated with 10 mM acetic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 110 mg/mL AM-14 formulated with 10 mM acetic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 120 mg/mL AM-14 formulated with 10 mM acetic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 130 mg/mL AM-14 formulated with 10 mM acetic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 140 mg/mL AM-14 formulated with 10 mM acetic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 150 mg/mL AM-14 formulated with 10 mM acetic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2.

Embodiments of AM-14 formulations include, but are not limited to, 100-150mg/mL AM-14 formulated with 5-15mM acetic acid, 2-4% w/v glycerol, 0.003-0.02 wt./vol.% polysorbate 20, pH 4.5-5.5±0.2. Embodiments of AM-14 formulations include approximately 105 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% glycerol, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 110 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% glycerol, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 120 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% glycerol, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 130 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% glycerol, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 140 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% glycerol, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2. Embodiments of AM-14 formulations include approximately 150 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% glycerol, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2.

Embodiments of AM-14 formulations include, but are not limited to, 100-150mg/mL AM-14 formulated with 5-15mM acetic acid, 3.5-5.5% w/v sorbitol, 0.003 -0.02 wt./vol.% polysorbate 20, pH 4.5-5.5±0.2. Embodiments of AM-14 formulations include approximately 105 mg/mL AM-14 formulated with 10 mM acetic acid, 4.5 w/v% sorbitol, 0.01 w/v% polysorbate 20, pH 4 .8±0.2. Embodiments of AM-14 formulations include approximately 110 mg/mL AM-14 formulated with 10 mM acetic acid, 4.5 w/v% sorbitol, 0.01 w/v% polysorbate 20, pH 4 .8±0.2. Embodiments of AM-14 formulations include approximately 120 mg/mL AM-14 formulated with 10 mM acetic acid, 4.5 w/v% sorbitol, 0.01 w/v% polysorbate 20, pH 4 .8±0.2. Embodiments of AM-14 formulations include approximately 130 mg/ml AM-14 formulated with 10 mM acetic acid, 4.5 w/v% sorbitol, 0.01 w/v% polysorbate 20, pH 4 .8±0.2. Embodiments of AM-14 formulations include approximately 140 mg/mL AM-14 formulated with 10 mM acetic acid, 4.5 w/v% sorbitol, 0.01 w/v% polysorbate 20, pH 4 .8±0.2. Embodiments of AM-14 formulations include approximately 150 mg/ml AM-14 formulated with 10 mM acetic acid, 4.5 w/v% sorbitol, 0.01 w/v% polysorbate 20, pH 4 .8±0.2.

Embodiments of AM-14 formulations include, but are not limited to, 100-150mg/mL AM-14 formulated with 5-15mM glutamic acid, 7-9% w/v sucrose, 0.003-0.02 wt./vol.% polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25°C. Embodiments of AM-14 formulations include approximately 105 mg/mL AM-14 formulated with 10 mM glutamic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 110 mg/mL of AM-14 formulated with

- 8040869 mM glutamic acid, 8% w/v sucrose, 0.01% w/v polysorbate 20, pH 4.8±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 120 mg/mL AM-14 formulated with 10 mM glutamic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 130 mg/mL AM-14 formulated with 10 mM glutamic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 140 mg/mL AM-14 formulated with 10 mM glutamic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 150 mg/mL AM-14 formulated with 10 mM glutamic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C.

Embodiments of AM-14 formulations include, but are not limited to, 100-150mg/mL AM-14 formulated with 5-15mM glutamic acid, 1-3% w/v glycine, 0.003-0.02 wt./vol.% polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25°C. Embodiments of AM-14 formulations include approximately 105 mg/mL AM-14 formulated with 10 mM glutamic acid, 2 w/v% glycine, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 110 mg/ml AM-14 formulated with 10 mM glutamic acid, 2% w/v% glycine, 0.01 w/v% polysorbate 20, pH 4, 8±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 120 mg/mL AM-14 formulated with 10 mM glutamic acid, 2% w/v% glycine, 0.01 w/v% polysorbate 20, pH 4, 8±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 130 mg/mL AM-14 formulated with 10 mM glutamic acid, 2% w/v% glycine, 0.01 w/v% polysorbate 20, pH 4, 8±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 140 mg/mL AM-14 formulated with 10 mM glutamic acid, 2% w/v% glycine, 0.01 w/v% polysorbate 20, pH 4, 8±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 150 mg/ml AM-14 formulated with 10 mM glutamic acid, 2% w/v% glycine, 0.01 w/v% polysorbate 20, pH 4, 8±0.2, 5-7 cP at 25°C.

Embodiments of AM-14 formulations include, but are not limited to, 100-150mg/mL AM-14 formulated with 5-15mM glutamic acid, 2-4% w/v proline, 0.003-0.02 wt./vol.% polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25°C. Embodiments of AM-14 formulations include approximately 105 mg/ml AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 110 mg/ml AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 120 mg/ml AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 130 mg/mL AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 140 mg/mL AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 150 mg/ml AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2, 5-7 cP at 25°C.

Embodiments of AM-14 formulations include, but are not limited to, 100-150mg/ml AM-14 formulated with 5-15mM acetic acid, 1-3% w/v glycine, 0.003-0.02 wt./vol.% polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25°C. Embodiments of AM-14 formulations include approximately 105 mg/mL AM-14 formulated with 10 mM acetic acid, 2 w/v% glycine, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 110 mg/mL AM-14 formulated with 10 mM acetic acid, 2 w/v% glycine, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 120 mg/mL AM-14 formulated with 10 mM acetic acid, 2 w/v% glycine, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 130 mg/ml AM-14 formulated with 10 mM acetic acid, 2 w/v% glycine, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 140 mg/mL AM-14 formulated with 10 mM acetic acid, 2 w/v% glycine, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 150 mg/mL AM-14 formulated with 10 mM acetic acid,

- 9 040869 wt./vol.% glycine, 0.01 wt./vol.% polysorbate 20, pH 4.8±0.2, 5-7 cP at 25°C.

Embodiments of AM-14 formulations include, but are not limited to, 100-150mg/mL AM-14 formulated with 5-15mM acetic acid, 2-4% w/v proline, 0.003-0.02 wt./vol.% polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25°C. Embodiments of AM-14 formulations include approximately 105 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 110 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 120 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 130 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 140 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 150 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4 .8±0.2, 5-7 cP at 25°C.

Embodiments of AM-14 formulations include, but are not limited to, 100-150mg/mL AM-14 formulated with 5-15mM acetic acid, 7-9w/v% sucrose, 0.003-0.02 wt./vol.% polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25°C. Embodiments of AM-14 formulations include approximately 105 mg/mL AM-14 formulated with 10 mM acetic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 110 mg/mL AM-14 formulated with 10 mM acetic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 120 mg/mL AM-14 formulated with 10 mM acetic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 130 mg/mL AM-14 formulated with 10 mM acetic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 140 mg/mL AM-14 formulated with 10 mM acetic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 150 mg/mL AM-14 formulated with 10 mM acetic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C.

Embodiments of AM-14 formulations include, but are not limited to, 100-150mg/mL AM-14 formulated with 5-15mM acetic acid, 2-4% w/v glycerol, 0.003-0.02 wt./vol.% polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25°C. Embodiments of AM-14 formulations include approximately 105 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% glycerol, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 110 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% glycerol, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 120 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% glycerol, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 130 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% glycerol, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 140 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% glycerol, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 150 mg/mL AM-14 formulated with 10 mM acetic acid, 3 w/v% glycerol, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, 5-7 cP at 25°C.

Embodiments of AM-14 formulations include, but are not limited to, 100-150mg/mL AM-14 formulated with 5-15mM acetic acid, 3.5-5.5% w/v sorbitol, 0.003 -0.02 wt./vol.% polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25°C. Embodiments of AM-14 formulations include approximately 105 mg/mL AM-14 formulated with 10 mM acetic acid, 4.5 w/v% sorbitol, 0.01 w/v% polysorbate 20, pH 4 .8±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 110 mg/mL AM-14 formulated with 10 mM acetic acid, 4.5 w/v% sorbitol, 0.01 w/v% polysorbate 20, pH 4 .8±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 120 mg/mL AM-14 formulated with 10 mM acetic acid, 4.5 w/v% sorbitol, 0.01 w/v% polysorbate 20,

- 10 040869 pH 4.8±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 130 mg/ml AM-14 formulated with 10 mM acetic acid, 4.5 w/v% sorbitol, 0.01 w/v% polysorbate 20, pH 4 .8±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 140 mg/mL AM-14 formulated with 10 mM acetic acid, 4.5 w/v% sorbitol, 0.01 w/v% polysorbate 20, pH 4 .8±0.2, 5-7 cP at 25°C. Embodiments of AM-14 formulations include approximately 150 mg/ml AM-14 formulated with 10 mM acetic acid, 4.5 w/v% sorbitol, 0.01 w/v% polysorbate 20, pH 4 .8±0.2, 5-7 cP at 25°C. The term approximately means ± 0.01-5.0%.

The stability of the AM-14 biopharmaceutical formulation of the invention refers to the retention of the structure and/or function of the biopharmaceutical in the formulation. The biopharmaceutical in the formulation of the invention exhibits properties such as resistance to change or damage that impair stability or function, and thus maintaining constant performance over time. Thus, AM-14 formulations may exhibit, for example, reliability and safety in terms of activity per unit volume or activity.

In one embodiment, the stability of the AM-14 biopharmaceutical in the formulation of the invention includes, for example, maintaining physical and/or chemical stability. The biopharmaceutical stability of AM-14 can be assessed, for example, by determining whether AM-14 has undergone physical and/or chemical degradation, including chemical modification of its structure. Stability can be measured by any means known in the art, such as measuring protein aggregates and/or protein degradation products using photometric and/or chromatographic methods. Maintaining the stability of AM-14 in the formulation includes, for example, maintaining physical and/or chemical stability between about 80-100%, including maintaining a stability of at least about 99, 98, 97, 96, 95, 94, 93, 92, 91 , 90%, 89%, 88%, 87%, 86%, 85%, 84%, 83%, 82%, 81%, or 80% compared to the initial stability of AM-14. Example 1 describes such stability studies and exemplary methods for measuring physical and/or chemical stability.

Embodiments include AM-14 formulations such as:

100-150mg/ml AM-14 formulated with 5-15mM glutamic acid, 7-9w/v% sucrose, 0.003-0.02w/v% polysorbate 20, pH 4.5 -5.5 ± 0.2, such as 140 mg/ml AM-14 formulated with 10 mM glutamic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20 , pH 4.8±0.2;

100-150mg/ml AM-14 formulated with 5-15mM glutamic acid, 1-3% w/v glycine, 0.003-0.02% w/v polysorbate 20, pH 4.5 -5.5 ± 0.2, such as 140 mg/ml AM-14 formulated with 10 mM glutamic acid, 2 w/v% glycine, 0.01 w/v% polysorbate 20 , pH 4.8±0.2;

100-1500mg/ml AM-14 formulated with 5-15mM glutamic acid, 2-4% w/v proline, 0.003-0.02% w/v polysorbate 20, pH 4.5 -5.5±0.2, such as approximately 140 mg/ml AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v. % polysorbate 20, pH 4.8±0.2, and 140 mg/ml AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v. % polysorbate 20, pH 4.8±0.2;

100-150mg/ml AM-14 formulated with 5-15mM acetic acid, 1-3% w/v glycine, 0.003-0.02% w/v polysorbate 20, pH 4.5 -5.5 ± 0.2, such as 140 mg/ml AM-14 formulated with 10 mM acetic acid, w/v% glycine, 0.01 w/v% polysorbate 20, pH 4.8±0.2;

100-150mg/ml AM-14 formulated with 5-15mM acetic acid, 2-4% w/v proline, 0.003-0.02% w/v polysorbate 20, pH 4.5 -5.5 ± 0.2, such as 140 mg/ml AM-14 formulated with 10 mM acetic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2;

100-150mg/ml AM-14 formulated with 5-15mM acetic acid, 7-9% w/v sucrose, 0.003-0.02% w/v polysorbate 20, pH 4.5 -5.5 ± 0.2, such as 140 mg/ml AM-14 formulated with 10 mM acetic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20 , pH 4.8±0.2;

100-150mg/ml AM-14 formulated with 5-15mM acetic acid, 2-4% w/v glycerol, 0.003-0.02% w/v polysorbate 20, pH 4.5 -5.5 ± 0.2, such as 140 mg/ml AM-14 formulated with 10 mM acetic acid, 3% w/v glycerol, 0.01% w/v polysorbate 20 , pH 4.8±0.2;

100-150mg/ml AM-14 formulated with 5-15mM acetic acid, 3.5-5.5% w/v sorbitol, 0.003-0.02% w/v polysorbate 20, pH 4.5-5.5±0.2, such as 140 mg/ml AM-14 formulated with 10 mM acetic acid, 4.5 w/v% sorbitol, 0.01 wt. /vol.% polysorbate 20, pH 4.8±0.2;

100-150mg/ml AM-14 formulated with 5-15mM glutamic acid, 7-9w/v% sucrose, 0.003-0.02w/v% polysorbate 20, pH 4.5 -5.5±0.2, 4-10 cP at 25°C, such as 140 mg/ml AM-14 formulated with 10 mM glutamic acid, 8 w/v% sucrose, 0. 01 w/v%

- 11 040869 polysorbate 20, pH 4.8±0.2, 5-7 cP at 25°C;

100-150mg/ml AM-14 formulated with 5-15mM glutamic acid, 1-3% w/v glycine, 0.003-0.02% w/v polysorbate 20, pH 4.5 -5.5±0.2, 4-10 cP at 25°C, such as 140 mg/ml

AM-14 formulated with 10 mM glutamic acid, 2 w/v% glycine, 0.01 w/v% polysorbate 20, pH 4.8±0.2, 5-7 cP at 25° WITH;

100-150mg/ml AM-14 formulated with 5-15mM glutamic acid, 2-4% w/v proline, 0.003-0.02% w/v polysorbate 20, pH 4.5 -5.5±0.2, 4-10 cP at 25°C, such as 140 mg/ml AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, 5-7 cP at 25°C;

100-150mg/ml AM-14 formulated with 5-15mM acetic acid, 1-3% w/v glycine, 0.003-0.02% w/v polysorbate 20, pH 4.5 -5.5±0.2, 4-10 cP at 25°C, such as 140 mg/ml AM-14 formulated with 10 mM acetic acid, 2 w/v% glycine, 0. 01% w/v polysorbate 20, pH 4.8±0.2, 5-7 cP at 25°C;

100-150mg/ml AM-14 formulated with 5-15mM acetic acid, 2-4% w/v proline, 0.003-0.02% w/v polysorbate 20, pH 4.5 -5.5±0.2, 4-10 cP at 25°C, such as 140 mg/ml AM-14 formulated with 10 mM acetic acid, 3 w/v% L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, 5-7 cP at 25°C;

100-150mg/ml AM-14 formulated with 5-15mM acetic acid, 7-9% w/v sucrose, 0.003-0.02% w/v polysorbate 20, pH 4.5 -5.5±0.2, 4-10 cP at 25°C, such as 140 mg/ml AM-14 formulated with 10 mM acetic acid, 8 w/v% sucrose, 0. 01% w/v polysorbate 20, pH 4.8±0.2, 5-7 cP at 25°C;

100-150mg/ml AM-14 formulated with 5-15mM acetic acid, 2-4% w/v glycerol, 0.003-0.02% w/v polysorbate 20, pH 4.5 -5.5±0.2, 4-10 cP at 25°C, such as 140 mg/ml AM-14 formulated with 10 mM acetic acid, 3 w/v% glycerol, 0. 01% w/v polysorbate 20, pH 4.8±0.2, 5-7 cP at 25°C;

100-150mg/ml AM-14 formulated with 5-15mM acetic acid, 3.5-5.5% w/v sorbitol, 0.003-0.02% w/v polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25°C, such as 140 mg/ml AM-14 formulated with 10 mM acetic acid, 4.5 w/v .% sorbitol, 0.01 wt./vol.% polysorbate 20, pH 4.8±0.2, 5-7 cP at 25°C, having a physical and/or chemical stability retention between approximately 80-100%, including stability retention of at least about 99%, 98%, 97%, 96%, 95%, 94%, 93%, 92%, 91%, 90%, 89%, 88%, 87%, 86%, 85%, 84%, 83%, 82%, 81%, or 80% with the stability of AM-14 at the initial point in time.

The biopharmaceutical composition of the invention can generally be prepared in accordance with pharmaceutical standards and using pharmaceutical grade reagents. Similarly, the biopharmaceutical composition of the invention can generally be prepared using sterile reagents under sterile manufacturing conditions or sterilized after preparation. Sterile injectable solutions can be prepared using well known methods in the art, including, for example, by incorporating AM-14 into the formulation described herein, followed by microfiltration sterilization. In a particular embodiment of sterile powders for preparing sterile injectable solutions, particularly suitable methods of preparation include, for example, vacuum drying and freeze drying (lyophilization) as previously described. Such drying methods produce a powder of one or more biopharmaceuticals along with additional desired components from a solution previously filtered by sterilization.

Embodiments include pharmaceutical containers containing a container and/or device with a container and an AM-14 pharmaceutical formulation as described herein. The container and/or container attachment is that which contains the pharmaceutical composition of AM-14 and can be any suitable container known in the art, including, but not limited to, vial, bottle, syringe, or any of a variety of formats, well known in the art for packaging pharmaceutical formulations, including subcutaneous and transdermal delivery devices. The syringe may be filled with pharmaceutical composition AM-14, as described herein, prior to delivery to end users (ie, a pre-filled syringe).

Embodiments of the invention include a pre-filled syringe containing the pharmaceutical formulation of AM-14 as described herein, wherein the pre-filled syringe is in the form of a self-injecting syringe such as, but not limited to, SureClick®, EverGentle®, Avanti®, DosePro® and Leva® or their version. Embodiments of the invention include a pre-filled syringe containing AM-14 at a concentration of approximately 140 mg/ml formulated with 10 mM glutamic acid, 3 w/v% L-proline,

- 12 040869

0.01% w/v polysorbate 20, pH 4.8±0.2, in the form of a self-injecting syringe such as, but not limited to, SureClick®, EverGentle®, Avanti®, DosePro® and Leva® or their version. Embodiments of the invention include a pre-filled syringe containing the pharmaceutical formulation of AM-14 as described herein, wherein the pre-filled syringe is in the form of any suitable microinfusion pump known in the art. Embodiments of the invention include a pre-filled syringe in the form of a microinfusion pump containing AM-14 at a concentration of approximately 140 mg/ml, formulated with 10 mm glutamic acid, 3 wt./vol.% L-proline, 0.01 wt. /vol.% polysorbate 20, pH 4.8±0.2. The microinfusion device is a microinfusion pump for subcutaneous drug delivery. Embodiments of the invention include transdermal delivery of the AM-14 pharmaceutical formulation as described herein. Embodiments of the invention include any transdermal delivery system containing AM-14 at a concentration of approximately 140 mg/ml formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4.8±0.2.

The kits are also embodiments of the invention and contain one or more of the pharmaceutical containers of AM-14 described in the preceding paragraphs, along with instructions for use of AM-14. It is understood that the kit may contain other components.

I. Formulations, Dosages and Treatment Modes.

AM-14 in a pharmaceutical composition containing AM-14 at a concentration of approximately 100-150 mg/mL formulated with 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and in particular AM-14 in a pharmaceutical composition containing AM-14 at a concentration of approximately 140 mg/ml, included in the composition with 10 mm glutamic acid, 3 wt./about. % L-proline, 0.01 w/v% polysorbate 20, pH 4.8 ± 0.2, can be used to treat adult, juvenile and/or pediatric patient populations with the disease, including but not limited to, IL-17 related inflammation IL-17 related autoimmune disease IL-17 related inflammation of cartilage and/or bone degradation Arthritis Rheumatoid arthritis SEA syndrome arthritis, systemic-onset rheumatoid arthritis, ankylosing spondylitis, enteropathic arthritis, reactive ar trititis, Reiter's syndrome, dermatomyositis, psoriatic arthritis, scleroderma, systemic lupus erythematosus, vasculitis, myolitis, polymyolitis, dermatomyolitis, osteoarthritis, polyarteritis nodosa, Wegener's granulomatosis, arteritis, polymyalgia rheumatica, sarcoidosis, scleroderma, sclerosis, primary biliary sclerosis, sclerosing cholangitis, Sjögren's syndrome, psoriasis, plaque psoriasis, guttate psoriasis, psoriasis inversus, pustular psoriasis, erythrodermal psoriasis, dermatitis, atopic dermatitis, atherosclerosis, lupus, Still's disease, systemic lupus erythematosus (SLE), myasthenia gravis, inflammatory bowel disease (IBD), Crohn's disease , ulcerative colitis, celiac disease, multiple sclerosis (MS), asthma, COPD, Guillain-Barré disease, type I diabetes mellitus, Graves' disease, Addison's disease, Raynaud's phenomenon, autoimmune hepatitis, GVHD, pernicious anemia, vitiligo, Kawasaki disease, associated with ANCA vasculitis, pemphigus, bullous pemphigoid, autoimmune ovarian failure, thyroiditis Ha shimoto, uveitis, thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, intermittent fever syndromes, familial Mediterranean fever, TNF-1 receptor-associated periodic syndrome, hyper-IgD syndrome, Marshall syndrome, cryopyrin-associated periodic syndromes, PAPA (pyogenic arthritis, pyoderma gangrenosum and acne), Blau's syndrome, interstitial pneumonia (such as ordinary interstitial pneumonia, desquamative interstitial pneumonia, respiratory bronchiolitis associated interstitial lung disease, acute interstitial pneumonia, nonspecific interstitial pneumonia, lymphocytic interstitial pneumonia, cryptogenic organizing pneumonitis), pulmonary fibrosis , fibrosing syndromes (such as scleredema, scleromyxedema, overlap syndromes, nephrogenic systemic fibrosis, amyloidosis, eosinophilic fasciitis, drug-induced chronic graft-versus-host disease of the sclera dermatitis, and fibrosis due to environmental exposure), neutrophilic dermatoses (such as pyoderma gangrenosum, SAPHO syndrome (synovitis, acne, pustulosis, hyperostosis, and osteitis), palmoplantar pustulosis, subcorneal pustular dermatosis, gut-associated arthritis dermatosis syndrome, Behcet's disease , neutrophilic dermatoses associated with rheumatoid arthritis, rheumatoid neutrophilic dermatosis, neutrophilic exocrine hidradenitis, and neutrophilic dermatosis of the dorsum of the hands), sepsis/SIRS, postcardiac injury syndrome, and Dressler's syndrome, idiopathic arthritis, and the like.

AM-14 in a pharmaceutical composition containing AM-14 at a concentration of approximately 140 mg/ml formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20 , pH 4.8 ± 0.2 can be used to treat adult, juvenile and / or pediatric patient groups with diseases including, but not limited to,

- 13 040869 IL-17 related inflammation, IL-17 related autoimmune disease, IL-17 related inflammation of cartilage and/or bone degradation, arthritis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, scleroderma, psoriasis, plaque psoriasis, guttate psoriasis, dermatitis, atopic dermatitis, inflammatory bowel disease (IBD), Crohn's disease, ulcerative colitis, celiac disease, multiple sclerosis (MS), asthma, and COPD.

AM-14 in a pharmaceutical composition containing AM-14 at a concentration of approximately 140 mg/ml formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20 , pH 4.8±0.2, can be used to treat adult, juvenile and/or pediatric patient groups with diseases including, but not limited to, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, plaque psoriasis, Crohn's disease , multiple sclerosis (MS) and asthma.

As described in examples 2 and 6, AM-14 shows efficacy in the treatment of psoriasis in human patients. Examples 2 and 6 provide clinical data on the efficacy of AM-14 in the treatment of psoriasis in human patients with psoriasis, in particular plaque psoriasis. Subcutaneous and intravenous administration of AM-14 significantly reduced the symptoms of psoriasis. Example 2 describes the reduction in psoriasis symptoms as measured by the industry-recognized PASI scoring system. In table. 2.8, 2.9, 2.10 and 2.11 show the PASI and %PASI scores (i.e., % reduction in PASI score).

Moreover, state-of-the-art PK-PD modeling was performed based on data from the phase 1 psoriasis trial (see Example 2). The predictive model correlated very closely with the true PASI response data (see FIG. 11), confirming the robustness of the predictive performance for various doses. In addition, in FIG. 12 shows the mean PASI response over time for different dose scenarios (over 12 weeks), including placebo effect, based on a model developed from single dose data. It was suggested that the simulated placebo response only works after the first dose. The median response for the 140 mg sc dose (at weeks 0, 1, 2, 4, 6, 8, 10) was expected to exceed the 50% improvement in PASI over most of the study period, including the primary efficacy outcome at 12 weeks (84 day). The mean response for s.c. doses of 210 and 280 mg (at weeks 0, 1, 2, 4, 6, 8, 10) was expected to exceed the 75% improvement in PASI over most of the study period, including the primary efficacy outcome at 12 weeks ( 84 days). Finally, in FIG. 13 shows the median percentage improvement in PASI at week 12 (dose-response curve) for AM-14 with 90% confidence interval highlighted by the shaded area; for various dose levels, each administered sc at weeks 0, 1, 2, 4, 6, 8 and 10.

Example 6 describes a phase 2 trial where AM-14 demonstrated significant efficacy in the treatment of psoriasis. Subjects received 70, 140, or 210 mg of AM-14 on day 1 and weeks 1, 2, 4, 6, 8, and 10, or 280 mg on day 1 and weeks 4 and 8. AM-14 showed the following PASI responses to 12 week:

70 mg dosing produced a 33.3% PASI 75 response;

70 mg dosing produced a 17.9% PASI 90 response;

70 mg dosing produced a 10.3% PASI 100 response;

140 mg dosing produced a 76.9% PASI 75 response;

140 mg dosing produced a 71.8% PASI 90 response;

140 mg dosing produced a 38.5% PASI 100 response;

210 mg dosing produced an 82.5% PASI 75 response;

210 mg dosing produced a 75.0% PASI 90 response;

210 mg dosing produced a 62.5% PASI 100 response;

280 mg dosing produced a 66.7% PASI 75 response;

280 mg dosing produced a 57.1% PASI 90 response;

280 mg dosing produced a 28.6% PASI 100 response.

Thus, administration of AM-14 at the dosages and schedules described herein can be used to reduce the PASI score in a patient with psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45 , 50, 55, 60, 65, 70, 75, 80, 85, 90, 95 or 100%.

Based on all these data, AM-14 can be used to treat the various forms of psoriasis described above, in particular plaque psoriasis, in adult and/or juvenile patients in the dose range of 70 to 1000 mg per dose, and in particular in the dose range 70 to 700 mg per dose. AM-14 can be used to treat psoriasis, in particular plaque psoriasis, in adult and/or juvenile patients with psoriasis at a dosage range of about 140 to about 300 mg per dose. AM-14 can be used to treat psoriasis, in particular plaque psoriasis, in adult and/or juvenile patients with psoriasis at a dose of

- 14 040869

70, 75, 80, 85 .90 95, 100, 105, 110 115 120 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195, 200, 205, 210, 215, 220, 225, 230, 235, 240, 245, 250, 255, 260, 265, 270, 275, 280, 285, 290, 295, 300, 305, 310, 315, 320, 325, 330, 335, 340, 345, 350, 355, 360, 365, 370, 375, 380, 385, 390, 395, 400, 405, 410, 415, 420, 425, 430, 435, 440, 445, 450, 455, 460, 465, 470, 475, 480, 485, 490, 495, 500, 505, 510, 515, 520, 525, 530, 535, 540, 545, 550, 555, 560, 565, 570, 575, 580, 585, 590, 595, 600, 605, 610, 615, 620, 625, 630, 635, 640, 645, 650, 655, 660, 665, 670, 675, 680, 685, 690, 695, 700, 705, 710, 715, 720, 725, 730, 735, 740, 745, 750, 755, 760, 765, 770, 775, 780, 785, 790, 795, 800, 805, 810, 815, 820, 825, 830, 835, 840, 845, 850, 855, 860, 865, 870, 875, 880, 885, 890, 895, 900 905, 910, 915, 920, 925, 930, 935, 940, 945, 950, 955, 960, 965, 970, 975, 980, 985, 990 .995 and or 1000 mg

per dose.

AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 70 mg per dose. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 140 mg per dose. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 210 mg per dose. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 280 mg per dose.

AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, particularly plaque psoriasis, with multiple doses of 70 mg per dose delivered by subcutaneous injection. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 140 mg per dose delivered by subcutaneous injection. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 210 mg per dose delivered by subcutaneous injection. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 280 mg per dose delivered by subcutaneous injection.

AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, particularly plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection administered at time 0 (first administration), one week after time point 0, and then every two weeks after administration in the first week. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time point 0, and then every two weeks after administration in the first week. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection administered at time 0 (first administration), one week after time point 0, and then every two weeks after administration in the first week. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time point 0, and then every two weeks after administration in the first week.

AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, particularly plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection administered at time 0 (first administration), one week after time point 0, and then once a month after administration in the first week. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time point 0, and then once a month after administration in the first week. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection administered at time 0 (first administration), one week after time point 0, and then once a month after administration in the first week.

- 15 040869

AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after point in time

0, and then carried out once a month after the introduction in the first week.

AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, particularly plaque psoriasis, with multiple doses of 70 mg per dose delivered by subcutaneous injection with a syringe. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, particularly plaque psoriasis, with multiple doses of 140 mg per dose delivered by subcutaneous injection with a syringe. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 210 mg per dose delivered by subcutaneous injection with a syringe. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 280 mg per dose delivered by subcutaneous injection with a syringe.

AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, particularly plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week later after time 0, and then every two weeks after administration in the first week. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week later after time 0, and then every two weeks after administration in the first week. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week later after time 0, and then every two weeks after administration in the first week. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week later after time 0, and then every two weeks after administration in the first week.

AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week later after time point 0, and then once a month after administration in the first week. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week later after time point 0, and then once a month after administration in the first week. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week later after time point 0, and then once a month after administration in the first week. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week later after time point 0, and then once a month after administration in the first week.

AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 70 mg per dose delivered by subcutaneous injection with a self-injection syringe. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, particularly plaque psoriasis, with multiple doses of 140 mg per dose delivered by subcutaneous injection with a self-injection syringe. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 210 mg per dose delivered by subcutaneous injection with a self-injection syringe. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, particularly plaque psoriasis, with multiple doses of 280 mg per dose delivered by subcutaneous injection with a self-injection syringe.

AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection with a self-injection syringe given at time 0 (first administration), through one week after time 0, and then every two weeks after administration in the first week. AM-14 can be used to treat psoriasis in adults and/or juvenile patients with

- 16 040869 psoriasis, in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection with a self-injection syringe given at time 0 (first administration), one week after time 0, and then every two weeks after introduction in the first week. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection with a self-injection syringe administered at time 0 (first administration), through one week after time 0, and then every two weeks after administration in the first week. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection with a self-injection syringe given at time 0 (first administration), through one week after time 0, and then every two weeks after administration in the first week.

AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection with a self-injection syringe given at time 0 (first administration), through one week after time 0, and then once a month after administration in the first week. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection with a self-injecting syringe given at time 0 (first administration), through one week after time 0, and then once a month after administration in the first week. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection with a self-injection syringe administered at time 0 (first administration), through one week after time 0, and then once a month after administration in the first week. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection with a self-injection syringe given at time 0 (first administration), through one week after time 0, and then once a month after administration in the first week.

AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, particularly plaque psoriasis, with at least one dose of 70 mg per dose delivered by subcutaneous injection using a microinfusion device. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, particularly plaque psoriasis, with at least one dose of 140 mg per dose delivered by subcutaneous injection using a microinfusion device. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, particularly plaque psoriasis, with at least one dose of 210 mg per dose delivered by subcutaneous injection using a microinfusion device. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, particularly plaque psoriasis, with at least one dose of 280 mg per dose delivered by subcutaneous injection using a microinfusion device.

AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection using a microinfusion device administered at time 0 (first administration) , one week after time 0, and then every two weeks after administration in the first week. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection using a microinfusion device administered at time 0 (first administration) , one week after time 0, and then every two weeks after administration in the first week. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection using a microinfusion device administered at time 0 (first administration) , one week after time 0, and then every two weeks after administration in the first week. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection using a microinfusion device administered at time 0 (first administration) , one week after time 0, and then every two weeks after administration in the first week.

AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection using a microinfusion device administered at time 0 (first administration) , one week after time 0, and then once a month after administration in the first week. AM-14 can be used to treat psoriasis in adults and/or juvenile patients who have

- 17 040869 psoriasis, in particular plaque psoriasis, at a dose of 140 mg per dose, delivered by subcutaneous injection using a microinfusion device, administered at time 0 (first administration), one week after time 0, and then administered once a month after the introduction in the first week. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection using a microinfusion device administered at time 0 (first administration) , one week after time 0, and then once a month after administration in the first week. AM-14 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection using a microinfusion device administered at time 0 (first administration) , one week after time 0, and then once a month after administration in the first week.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 70 mg per dose. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 140 mg per dose. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 210 mg per dose. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 280 mg per dose AM-14 can be used to treat adults and/ or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 70 mg per dose delivered by subcutaneous injection. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 140 mg per dose delivered by subcutaneous injection. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 210 mg per dose delivered by subcutaneous injection. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 280 mg per dose delivered by subcutaneous injection.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection administered at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 can be

- 18 040869 to change for the treatment of adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, at a dose of 210 mg per dose delivered by subcutaneous injection given at time 0 (first administration ), one week after time 0, and then once a month after administration in the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 70 mg per dose delivered by subcutaneous injection with a syringe. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 140 mg per dose delivered by subcutaneous injection with a syringe. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 210 mg per dose delivered by subcutaneous injection with a syringe. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 280 mg per dose delivered by subcutaneous injection with a syringe.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection with a syringe given at time 0 ( first injection), one week after time 0, and then every two weeks after the first week of administration. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection with a syringe given at time 0 ( first injection), one week after time 0, and then every two weeks after the first week of administration. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection with a syringe given at time 0 ( first injection), one week after time 0, and then every two weeks after the first week of administration.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection with a syringe given at time 0 ( first injection), one week after time 0, and then every two weeks after the first week of administration.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection with a syringe given at time 0 ( first injection), one week after time 0, and then once a month after administration in the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection with a syringe given at time 0 ( first injection), one week after time 0, and then once a month after administration in the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection with a syringe given at time 0 ( first injection), one week after time 0, and then once a month after administration in the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection with a syringe given at time 0 ( first injection), one week after time 0, and then once a month after administration in the first week.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy.

- 19 040869 or phototherapy, with repeated administration at a dose of 70 mg per dose delivered by subcutaneous injection with a syringe for self-injection. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 140 mg per dose delivered by subcutaneous injection with a self-injecting syringe. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 210 mg per dose delivered by subcutaneous injection with a self-injection syringe. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 280 mg per dose delivered by subcutaneous injection with a self-injection syringe.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection with a self-injecting syringe administered at time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection with a self-injecting syringe given at time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection with a self-injecting syringe administered at time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection with a self-injecting syringe given at time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection with a self-injecting syringe administered at time 0 (first injection), one week after time 0, and then once a month after the first week of administration. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection with a self-injecting syringe given at time 0 (first injection), one week after time 0, and then once a month after the first week of administration. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection with a self-injecting syringe administered at time 0 (first injection), one week after time 0, and then once a month after the first week of administration. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection with a self-injecting syringe given at time 0 (first injection), one week after time 0, and then once a month after the first week of administration.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 70 mg per dose delivered by subcutaneous injection using a microinfusion device . AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 140 mg per dose delivered by subcutaneous injection using a microinfusion device . AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 210 mg per dose delivered by subcutaneous injection using a microinfusion device . AM-14 can be used to treat adults

- 20 040869 and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses

280 mg per dose delivered by subcutaneous injection using a microinfusion device.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection using an intravenous microinfusion device. time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection using a microinfusion device administered in time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection using an intravenous microinfusion device. time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection using an intravenous microinfusion device. time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection using an intravenous microinfusion device. time 0 (first injection), one week after time 0, and then once a month after the first week of administration. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection using a microinfusion device administered in time 0 (first injection), one week after time 0, and then once a month after the first week of administration. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection using an intravenous microinfusion device. time 0 (first injection), one week after time 0, and then once a month after the first week of administration. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection using an intravenous microinfusion device. time 0 (first injection), one week after time 0, and then once a month after the first week of administration.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), with repeated administration at a dose of 70 mg per dose. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), with repeated administration at a dose of 140 mg per dose. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), with repeated administration at a dose of 210 mg per dose.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), with repeated administration at a dose of 280 mg per dose.

AM-14 can be used in adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (phototherapy with psoralen and ultraviolet light). radiation-A), with repeated administration at a dose of 70 mg per dose delivered by subcutaneous injection. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), with repeated administration at a dose of 140 mg per dose delivered by subcutaneous injection. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), with repeated administration at a dose of 210 mg per dose delivered by subcutaneous injection. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), with repeated administration at a dose of 280 mg per dose delivered by subcutaneous injection.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 70 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 140 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 210 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 280 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 70 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then once a month after administration for the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 140 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 210 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 280 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then once a month after administration for the first week.

- 22 040869

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), with repeated administration at a dose of 70 mg per dose delivered by subcutaneous injection with a syringe. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), with repeated administration at a dose of 140 mg per dose delivered by subcutaneous injection with a syringe. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), with repeated administration at a dose of 210 mg per dose delivered by subcutaneous injection with a syringe. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), with repeated administration at a dose of 280 mg per dose delivered by subcutaneous injection with a syringe.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 70 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 140 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 210 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 280 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 70 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 140 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 210 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (phototherapy with psoralen and ultraviolet-A), at a dose of 280 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), with repeated administration at a dose of 70 mg per dose delivered by subcutaneous injection with a syringe for self-injection. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), with repeated administration at a dose of 140 mg per dose delivered by subcutaneous injection with a syringe for self-injection. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), with repeated administration at a dose of 210 mg per dose delivered by subcutaneous injection with a syringe for self-injection. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), with repeated administration at a dose of 280 mg per dose delivered by subcutaneous injection with a syringe for self-injection.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 70 mg per dose delivered by subcutaneous injection with a self-injecting syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 140 mg per dose delivered by subcutaneous injection with a self-injecting syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 210 mg per dose delivered by subcutaneous injection with a self-injecting syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 280 mg per dose delivered by subcutaneous injection with a self-injecting syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 70 mg per dose delivered by subcutaneous injection with a self-injecting syringe given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 140 mg per dose delivered by subcutaneous injection with a self-injecting syringe given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or not

- 24 040869 tolerate other systemic therapies, including cyclosporine, methotrexate, and PUVA (phototherapy with psoralen and ultraviolet radiation-A), at a dose of 210 mg per dose delivered by subcutaneous injection with a self-injection syringe given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 280 mg per dose delivered by subcutaneous injection with a self-injecting syringe given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), with repeated administration at a dose of 70 mg per dose, delivered by subcutaneous injection using a microinfusion device. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), with repeated administration at a dose of 140 mg per dose, delivered by subcutaneous injection using a microinfusion device. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), with repeated administration at a dose of 210 mg per dose, delivered by subcutaneous injection using a microinfusion device. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), with repeated administration at a dose of 280 mg per dose, delivered by subcutaneous injection using a microinfusion device.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 70 mg per dose delivered by subcutaneous injection with a microinfusion device given at time 0 (first injection), one week after time 0, and then every two weeks after administration for the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 140 mg per dose delivered by subcutaneous injection with a microinfusion device given at time 0 (first injection), one week after time 0, and then every two weeks after administration for the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 210 mg per dose delivered by subcutaneous injection with a microinfusion device given at time 0 (first injection), one week after time 0, and then every two weeks after administration for the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 280 mg per dose delivered by subcutaneous injection with a microinfusion device given at time 0 (first injection), one week after time 0, and then every two weeks after administration for the first week.

AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 70 mg per dose delivered by subcutaneous injection using a microinfusion device, given at time 0 (first injection), one week after time 0, and then once a month after administration in the first week. AM-14 can be used to treat adult and/or juvenile patients with chronic

- 25 040869 moderate to severe plaque psoriasis who do not respond to, contraindicate, or tolerate other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen and ultraviolet light-A phototherapy), at a dose of 140 mg per dose delivered by subcutaneous injection with a microinfusion device given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 210 mg per dose delivered by subcutaneous injection using a microinfusion device, given at time 0 (first injection), one week after time 0, and then once a month after administration in the first week. AM-14 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A). ), at a dose of 280 mg per dose delivered by subcutaneous injection using a microinfusion device, given at time 0 (first injection), one week after time 0, and then once a month after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 70 mg per dose. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 140 mg per dose. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 210 mg per dose. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 280 mg per dose.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 70 mg per dose delivered by subcutaneous injection. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 140 mg per dose delivered by subcutaneous injection. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 210 mg per dose delivered by subcutaneous injection. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 280 mg per dose delivered by subcutaneous injection.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile psoriasis in patients with psoriasis, in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time time 0, and then carried out every two weeks after the introduction in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time time 0, and then carried out every two weeks after the introduction in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time time 0 and then every two

- 26 040869 weeks after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time time 0, and then carried out every two weeks after the introduction in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time time 0, and then once a month after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 70 mg per dose delivered by subcutaneous injection with a syringe. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 140 mg per dose delivered by subcutaneous injection with a syringe. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 210 mg per dose delivered by subcutaneous injection with a syringe. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 280 mg per dose delivered by subcutaneous injection with a syringe.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time point 0, and then every two weeks after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time point 0, and then every two weeks after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection with a syringe administered at time 0 (first administration), one week after time point 0, and then every two weeks after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adults and/or juvenile patients with

- 27 040869 psoriasis, in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time 0 and then every two weeks after administration at first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time point 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time point 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in patients with psoriasis, in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection with a syringe administered at time 0 (first administration), one week after time 0, and then administered once a month after the introduction in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time point 0, and then once a month after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 70 mg per dose delivered by subcutaneous injection with a self-injection syringe. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 140 mg per dose delivered by subcutaneous injection with a self-injection syringe. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with repeated administration at a dose of 210 mg per dose delivered by subcutaneous injection with a self-injection syringe. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with repeated administration at a dose of 280 mg per dose delivered by subcutaneous injection with a self-injection syringe.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection with a self-injection syringe given at time 0 (first administration), every other week after time 0, and then every two weeks after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection with a self-injection syringe administered at time 0 (first administration), every other week after time 0, and then every two weeks after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection with a self-injection syringe given at time 0 (first administration), every other week after time 0, and then every two weeks after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection with a self-injection syringe administered at time 0 (first administration), every other week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection with a self-injection syringe given at time 0 (first administration), every other week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection with a self-injection syringe administered at time 0 (first administration), every other week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection with a self-injection syringe given at time 0 (first administration), every other week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection with a self-injection syringe administered at time 0 (first administration), every other week after time 0, and then once a month after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, particularly plaque psoriasis, with multiple doses of 70 mg per dose delivered by subcutaneous injection using a microinfusion device. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, with multiple doses of 140 mg per dose delivered by subcutaneous injection using a microinfusion device. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, particularly plaque psoriasis, with multiple doses of 210 mg per dose delivered by subcutaneous injection using a microinfusion device. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, particularly plaque psoriasis, with multiple doses of 280 mg per dose delivered by subcutaneous injection using a microinfusion device.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection using a microinfusion device administered at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection using a microinfusion device administered at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection with a microinfusion device administered at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection using a microinfusion device administered at time 0 (first administration), through

- 29 040869 one week after time 0 and then every two weeks after the first week of administration.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 70 mg per dose delivered by subcutaneous injection using a microinfusion device administered at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 140 mg per dose delivered by subcutaneous injection using a microinfusion device administered at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 210 mg per dose delivered by subcutaneous injection with a microinfusion device administered at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, at a dose of 280 mg per dose delivered by subcutaneous injection using a microinfusion device administered at time 0 (first administration), one week after time 0, and then once a month after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 70 mg per dose. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 140 mg per dose. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 210 mg per dose. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 280 mg per dose. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 70 mg per dose delivered by subcutaneous injection. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 140 mg per dose delivered by subcutaneous injection. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 210 mg per dose delivered by subcutaneous injection. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 280 mg per dose delivered by subcutaneous injection.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, at a dose of 70 mg per dose delivered by subcutaneous injection given at the time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection administered at time 0 (first administration ), one week after time 0, and then every two weeks after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection administered at time 0 (first administration ), one week after time 0, and then every two weeks after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection administered at time 0 (first administration ), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection administered at time 0 (first administration ), one week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection administered at time 0 (first administration ), one week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection administered at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection administered at time 0 (first administration ), one week after time 0, and then once a month after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 70 mg per dose delivered by subcutaneous injection with a syringe. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 140 mg per dose delivered by subcutaneous injection with a syringe. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 210 mg per dose delivered by subcutaneous injection with a syringe. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with chronic plaque

- 31 040869 moderate to severe psoriasis, which are candidates for systemic therapy or phototherapy, with repeated administration at a dose of 280 mg per dose delivered by subcutaneous injection with a syringe.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous syringe injection given at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection with a syringe administered at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous syringe injection given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection with a syringe administered at time 0 (first administration), one week after time 0, and then once a month after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 70 mg per dose delivered by subcutaneous injection with a self-injecting syringe. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 140 mg per dose delivered by subcutaneous injection with a self-injecting syringe. AM-14 in a formulation containing 140 mg/mL AM-14, 10 mM

- 32 040869 glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, can be used to treat adult and/or juvenile patients with chronic moderate to severe plaque psoriasis that are candidates for systemic therapy or phototherapy, with repeated administration at a dose of 210 mg per dose delivered by subcutaneous injection with a self-injection syringe. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, with multiple doses of 280 mg per dose delivered by subcutaneous injection with a self-injecting syringe.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection with a self-injection syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection with a self-injection syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection with a self-injection syringe administered at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, at a dose of 280 mg per dose delivered by subcutaneous injection with a self-injection syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 70 mg per dose delivered by subcutaneous injection with a self-injection syringe given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection with a self-injection syringe given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 210 mg per dose delivered by subcutaneous injection with a self-injection syringe administered at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, at a dose of 280 mg per dose delivered by subcutaneous injection with a self-injection syringe given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2, can be used to treat adults and / or juvenile

- 33,040,869 patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy with at least one dose of 70 mg per dose delivered by subcutaneous injection using a microinfusion device. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy with at least one dose of 140 mg per dose delivered by subcutaneous injection using a device for microinfusion. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy with at least one dose of 210 mg per dose delivered by subcutaneous injection using the device for microinfusion. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy with at least one dose of 280 mg per dose delivered by subcutaneous injection using a device for microinfusion.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, at a dose of 70 mg per dose delivered by subcutaneous injection using a microinfusion device administered at the moment time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection using a microinfusion device administered at the moment time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, at a dose of 210 mg per dose delivered by subcutaneous injection using a microinfusion device administered at the moment time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, at a dose of 280 mg per dose delivered by subcutaneous injection using a microinfusion device delivered at the moment time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, at a dose of 70 mg per dose delivered by subcutaneous injection using a microinfusion device administered at the moment time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 140 mg per dose delivered by subcutaneous injection using a microinfusion device administered at the moment time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, at a dose of 210 mg per dose delivered by subcutaneous injection using a microinfusion device administered at the moment time 0 (first injection), one week after time 0, and then

- 34 040869 Dima once a month after the introduction in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy at a dose of 280 mg per dose delivered by subcutaneous injection using a microinfusion device delivered at the moment time 0 (first administration), one week after time 0, and then once a month after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , with repeated administration at a dose of 70 mg per dose. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , with repeated administration at a dose of 140 mg per dose. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , with repeated administration at a dose of 210 mg per dose. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , with repeated administration at a dose of 280 mg per dose. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , with repeated administration at a dose of 70 mg per dose delivered by subcutaneous injection. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , with repeated administration at a dose of 140 mg per dose delivered by subcutaneous injection. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) , with repeated administration at a dose of 210 mg per dose delivered by subcutaneous injection. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) , with repeated administration at a dose of 280 mg per dose delivered by subcutaneous injection.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 70 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2, can be used for treatment

- 35 040869 adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who do not respond, have contraindications, or cannot tolerate other systemic therapies, including cyclosporine, methotrexate, and PUVA (phototherapy with psoralen and ultraviolet light-A), at a dose 140 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 210 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 280 mg per dose delivered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , with repeated administration at a dose of 70 mg per dose delivered by subcutaneous injection with a syringe. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , with repeated administration at a dose of 140 mg per dose delivered by subcutaneous injection with a syringe. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , with repeated administration at a dose of 210 mg per dose delivered by subcutaneous injection with a syringe. AM-14 in a formulation containing 140 mg/ml AM14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including ciclosporin, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A), with repeated administration at a dose of 280 mg per dose, by subcutaneous injection with a syringe.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 70 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 140 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with chronic plaque

- 36 040869 moderate to severe psoriasis who do not respond to, have contraindications or do not tolerate other systemic therapies, including cyclosporine, methotrexate, and PUVA (phototherapy with psoralen and ultraviolet light-A), at a dose of 210 mg per dose delivered by subcutaneous injection syringe administered at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 280 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 70 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 140 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time 0, and then once a month after administration for the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 210 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time 0, and then once a month after administration for the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 280 mg per dose delivered by subcutaneous injection with a syringe given at time 0 (first administration), one week after time 0, and then once a month after administration for the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , with repeated administration at a dose of 70 mg per dose delivered by subcutaneous injection with a syringe for self-injection. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , with repeated administration at a dose of 140 mg per dose delivered by subcutaneous injection with a syringe for self-injection. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , with repeated administration at a dose of 210 mg per dose delivered by subcutaneous injection with a syringe for self-injection. AM-14 in a formulation containing 140 mg/mL AM-14, 10 mM glutamic acid, 3% w/v

- 37 040869

L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated or do not tolerate other systemic therapies, including cyclosporine, methotrexate, and PUVA (phototherapy with psoralen and ultraviolet light-A), with multiple doses of 280 mg per dose delivered by subcutaneous injection with a self-injection syringe.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 70 mg per dose delivered by subcutaneous injection with a self-injecting syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 140 mg per dose delivered by subcutaneous injection with a self-injecting syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 210 mg per dose delivered by subcutaneous injection with a self-injecting syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 280 mg per dose delivered by subcutaneous injection with a self-injecting syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 70 mg per dose delivered by subcutaneous injection with a self-injecting syringe given at time 0 (first administration), one week after time 0, and then once a month after administration for the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 140 mg per dose delivered by subcutaneous injection with a self-injecting syringe given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 210 mg per dose delivered by subcutaneous injection with a self-injecting syringe given at time 0 (first administration), one week after time 0, and then once a month after administration for the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (phototherapy with psoralen and ultraviolet light). radiation A), at a dose of 280 mg per dose delivered by subcutaneous injection with a self-injecting syringe given at time 0 (first administration), one week after time 0, and then once a month after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) with at least one dose of 70 mg per dose delivered by subcutaneous injection using a microinfusion device. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) with at least one dose of 140 mg per dose delivered by subcutaneous injection using a microinfusion device. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) with at least one dose of 210 mg per dose delivered by subcutaneous injection using a microinfusion device. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) with at least one dose of 280 mg per dose delivered by subcutaneous injection using a microinfusion device.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 70 mg per dose delivered by subcutaneous injection with a microinfusion device given at time 0 (first injection), one week after time 0, and then every two weeks after administration for the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 140 mg per dose delivered by subcutaneous injection with a microinfusion device given at time 0 (first injection), one week after time 0, and then every two weeks after administration for the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light A), in dose of 210 mg per dose delivered by subcutaneous injection with a microinfusion device given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 280 mg per dose delivered by subcutaneous injection with a microinfusion device given at time 0 (first injection), one week after time 0, and then every two weeks after administration for the first week.

- 39 040869

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 70 mg per dose delivered by subcutaneous injection with a microinfusion device given at time 0 (first injection), one week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 140 mg per dose delivered by subcutaneous injection with a microinfusion device given at time 0 (first injection), one week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 210 mg per dose delivered by subcutaneous injection using a microinfusion device, given at time 0 (first injection), one week after time 0, and then once a month after administration in the first week. AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) , at a dose of 280 mg per dose delivered by subcutaneous injection using a microinfusion device, given at time 0 (first injection), one week after time 0, and then once a month after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg when the patients weigh less than or about 90 kg every two weeks and when the patients weigh exceeds 90 kg, they are given a dose of 210 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg every two weeks when the patients weigh less than or approximately equal to 100 kg and when the patients weigh exceeds 100 kg, they are given a dose of 210 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg every two weeks when the patients weigh less than or approximately equal to 110 kg and when the patients weigh exceeds 110 kg, they are given a dose of 210 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg every two weeks when the patients weigh less than or about 90 kg and when the patients weigh exceeds 90 kg, they are given a dose of 280 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg every two weeks when the patients weigh less than or approximately equal to 100 kg and when the patients weigh exceeds 100 kg, they are given a dose of 280 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg every two weeks when the patients weigh less than or approximately equal to 110 kg and when the patients weigh exceeds 110 kg, they are given a dose of 280 mg every two weeks.

- 40 040869

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 280 mg every four weeks when the patients weigh less than or about 90 kg and when the patients weigh exceeds 90 kg, they are given a dose of 210 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 280 mg every four weeks when the patients weigh less than or approximately equal to 100 kg and when the patients weigh exceeds 100 kg, they are given a dose of 210 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 280 mg every four weeks when the patients weigh less than or approximately equal to 110 kg and when the patients weigh exceeds 110 kg, they are given a dose of 210 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 280 mg every four weeks when the patients weigh less than or about 90 kg and when the patients weigh exceeds 90 kg, they are given a dose of 280 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 280 mg every four weeks when the patients weigh less than or about 100 kg and when the patients weigh exceeds 100 kg, they are given a dose of 280 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 280 mg when the weight of the patients is less than or approximately equal to 110 kg and when the weight of the patients is greater than 110 kg , they are given a dose of 280 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg by subcutaneous injection when the patients weigh less than or about 90 kg every two weeks, and when patients weigh more than 90 kg, they are given a dose of 210 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg by subcutaneous injection every two weeks when the patients weigh less than or approximately equal to 100 kg, and, when patients weigh more than 100 kg, they are given a dose of 210 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg by subcutaneous injection every two weeks when the patients weigh less than or approximately equal to 110 kg, and, when patients weigh more than 110 kg, they are given a dose of 210 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg by subcutaneous injection every two weeks when the patients weigh less than or approximately equal to 90 kg, and, when patients weigh more than 90 kg, they are given a dose of 280 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2, Can be used to treat psoriasis in adults

- 41 040869 and / or juvenile patients with psoriasis, in particular plaque psoriasis, where these patients are administered a dose of 140 mg by subcutaneous injection every two weeks, when the weight of the patients is less than or approximately equal to 100 kg, and when the weight of the patients exceeds

100 kg, they are given a dose of 280 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg by subcutaneous injection every two weeks when the patients weigh less than or approximately equal to 110 kg, and, when patients weigh more than 110 kg, they are given a dose of 280 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 280 mg by subcutaneous injection every four weeks when the patients weigh less than or approximately equal to 90 kg, and, when patients weigh more than 90 kg, they are given a dose of 210 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 280 mg by subcutaneous injection every four weeks when the patients weigh less than or approximately equal to 100 kg, and, when patients weigh more than 100 kg, they are given a dose of 210 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed with 280 mg by subcutaneous injection every four weeks when the patients weigh less than or approximately equal to 110 kg, and, when patients weigh more than 110 kg, they are given a dose of 210 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 280 mg by subcutaneous injection every four weeks when the patients weigh less than or approximately equal to 90 kg, and, when patients weigh more than 90 kg, they are given a dose of 280 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 280 mg by subcutaneous injection every four weeks when the patients weigh less than or approximately equal to 100 kg, and, when patients weigh more than 100 kg, they are given a dose of 280 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 280 mg by subcutaneous injection every four weeks when the patients weigh less than or approximately equal to 110 kg, and, when patients weigh more than 110 kg, they are given a dose of 280 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are administered a dose of 140 mg delivered by subcutaneous injection with a self-injecting syringe when the patients weigh less than or approximately equal to 90 kg every two weeks, and when patients weigh more than 90 kg, they are given a dose of 210 mg delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 140 mg delivered by subcutaneous injection with a self-injection syringe every two weeks when the weight of the patients is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are administered a dose of 210 mg, delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v

- 42 040869

L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 140 mg delivered by subcutaneous injection with a self-injection syringe every two weeks when patients weigh less than or approximately equal to 110 kg, and when patients weigh more than 110 kg, they are given a dose of 210 mg delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 140 mg delivered by subcutaneous injection with a self-injection syringe every two weeks when the patients' weight is less than or approximately equal to 90 kg, and when the weight of patients exceeds 90 kg, they are administered a dose of 280 mg, delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 140 mg delivered by subcutaneous injection with a self-injection syringe every two weeks when the patients' weight is less than or approximately equal to 100 kg, and when patients weigh more than 100 kg, they are given a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 140 mg delivered by subcutaneous injection with a self-injection syringe every two weeks when the weight of the patients is less than or approximately equal to 110 kg, and when patients weigh more than 110 kg, they are given a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every four weeks when the patient's weight is less than or approximately equal to 90 kg, and when patients weigh more than 90 kg, they are given a dose of 210 mg delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every four weeks when the patient's weight is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are administered a dose of 210 mg, delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every four weeks when the patient's weight is less than or approximately equal to 110 kg, and when patients weigh more than 110 kg, they are given a dose of 210 mg delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every four weeks when the patient's weight is less than or approximately equal to 90 kg, and when patients weigh more than 90 kg, they are given a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every four weeks when the patient's weight is less than or approximately equal to 100 kg, and when patients weigh more than 100 kg, they are given a dose of 280 mg delivered by subcutaneous injection

- 43 040869 with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every four weeks when the patient's weight is less than or approximately equal to 110 kg, and when patients weigh more than 110 kg, they are given a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 140 mg delivered by subcutaneous injection using a microinfusion device when the weight of the patients is less than or approximately equal to 90 kg every two weeks, and when the weight of patients exceeds 90 kg, they are administered a dose of 210 mg, delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 140 mg delivered by subcutaneous injection using a microinfusion device every two weeks when the patients are underweight or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are administered a dose of 210 mg, delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 140 mg delivered by subcutaneous injection using a microinfusion device every two weeks when the patients are underweight or is approximately 110 kg, and when the weight of patients exceeds 110 kg, they are administered a dose of 210 mg, delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 140 mg delivered by subcutaneous injection using a microinfusion device every two weeks when the patients are underweight or approximately equal to 90 kg, and when the weight of patients exceeds 90 kg, they are administered a dose of 280 mg, delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 140 mg delivered by subcutaneous injection using a microinfusion device every two weeks when the patients are underweight or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are administered a dose of 280 mg, delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 140 mg delivered by subcutaneous injection using a microinfusion device every two weeks when the patients are underweight or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are administered a dose of 280 mg, delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used for the treatment of psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every four weeks when the patient's weight is less than or approximately equal to 90 kg, and when the weight of patients exceeds 90 kg, they are administered a dose of 210 mg, delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 280 mg delivered by subcutaneous injection using a device for

- 44 040869 microinfusions every four weeks when patients weigh less than or approximately equal to 100 kg, and when patients weigh more than 100 kg, they are administered a dose of 210 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used for the treatment of psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every four weeks when the patient's weight is less than or is approximately 110 kg, and when the weight of patients exceeds 110 kg, they are administered a dose of 210 mg, delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used for the treatment of psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every four weeks when the patient's weight is less than or approximately equal to 90 kg, and when the weight of patients exceeds 90 kg, they are administered a dose of 280 mg, delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used for the treatment of psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every four weeks when the patient's weight is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are administered a dose of 280 mg, delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used for the treatment of psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every four weeks when the patient's weight is less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are administered a dose of 280 mg, delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 90 kg and when the patients weigh more than 90 kg , they are dosed with 210 mg, where AM-14 is administered by subcutaneous injection at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 100 kg and when the patients weigh more than 100 kg , they are dosed with 210 mg, where AM-14 is administered by subcutaneous injection at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg when the patients weigh less than or about 110 kg and when the patients weigh more than 110 kg , they are dosed with 210 mg, where AM-14 is administered by subcutaneous injection at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat psoriasis in adult and/or juvenile patients having psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg when the patients weigh less than or about 90 kg and when the patients weigh more than 90 kg , they are dosed with 280 mg, where AM-14 is administered by subcutaneous injection at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in patients with psoriasis, in particular plaque psoriasis, where said patients are dosed

140 mg when the weight of patients is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are administered a dose of 280 mg, where AM-14 is administered by subcutaneous injection conducted at time 0 (first administration), through one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg when the patients weigh less than or about 110 kg and when the patients weigh more than 110 kg , they are dosed with 280 mg, where AM-14 is administered by subcutaneous injection at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 280 mg when the patients weigh less than or approximately equal to 90 kg and when the patients weigh more than 90 kg , they are dosed with 210 mg, where AM-14 is administered by subcutaneous injection at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are dosed at 280 mg at time 0 (first administration), one week after time 0 and every four weeks when the weight of patients is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are dosed with 210 mg at time 0 (first administration), one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are dosed at 280 mg at time 0 (first administration), one week after time 0 and every four weeks when the weight of patients is less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are dosed with 210 mg at time 0 (first administration), one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 280 mg at time 0 (first administration), one week after time 0 and every four weeks when the weight of patients is less than or approximately equal to 90 kg, and when the weight of patients exceeds 90 kg, they are dosed with 280 mg at time 0 (first administration), one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are dosed at 280 mg at time 0 (first administration), one week after time 0 and every four weeks when the weight of patients is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are dosed with 280 mg at time 0 (first administration), one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are dosed at 280 mg at time 0 (first administration), one week after time 0 and every four weeks when the weight of patients is less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are dosed with 280 mg at time 0 (first administration), one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 90 kg and when the patients weigh more than 90 kg , they are given a dose of 210 mg, where AM-14 is administered by subcutaneous injection with a self-injection syringe given at time 0 (first injection), one week after time 0, and then every two weeks after administration at the first non-46 040869 case.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 100 kg and when the patients weigh more than 100 kg , they are dosed with 210 mg, where AM-14 is administered by subcutaneous injection with a self-injection syringe given at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg when the patients weigh less than or about 110 kg and when the patients weigh more than 110 kg , they are dosed with 210 mg, where AM-14 is administered by subcutaneous injection with a self-injection syringe given at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 90 kg and when the patients weigh more than 90 kg , they are dosed at 280 mg where AM-14 is administered by subcutaneous injection with a self-injection syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 100 kg and when the patients weigh more than 100 kg , they are dosed with 280 mg, where AM-14 is administered by subcutaneous injection with a self-injection syringe given at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg when the patients weigh less than or about 110 kg and when the patients weigh more than 110 kg , they are dosed at 280 mg where AM-14 is administered by subcutaneous injection with a self-injection syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration for the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 280 mg when the patients weigh less than or approximately equal to 90 kg and when the patients weigh more than 90 kg , they are dosed with 210 mg, where AM-14 is administered by subcutaneous injection with a self-injection syringe given at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered by subcutaneous injection with a self-injection syringe at a dose of 280 mg at time 0 (first administration), one week after time 0 and every four weeks when the weight of patients is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are dosed with 210 mg at time 0 (first administration), one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered by subcutaneous injection with a self-injection syringe of a dose of 280 mg per

- 47 040869 time 0 (first administration), one week after time 0 and every four weeks when patients weigh less than or approximately equal to 110 kg, and when patients weigh more than 110 kg, they are administered a dose of 210 mg at time time 0 (first administration), one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered by subcutaneous injection with a self-injection syringe at a dose of 280 mg at time 0 (first administration), one week after time 0 and every four weeks when patients weigh less than or approximately equal to 90 kg, and when patients weigh more than 90 kg, they are dosed with 280 mg at time 0 (first administration), one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered by subcutaneous injection with a self-injection syringe at a dose of 280 mg at time 0 (first administration), one week after time 0 and every four weeks when the weight of patients is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are dosed with 280 mg at time 0 (first administration), one week after time 0 and every two weeks.

M-14 in a flask containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat psoriasis in adult and/or juvenile patients having psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg when the patients weigh less than or about 90 kg and when the patients weigh more than 90 kg , they are dosed at 210 mg where AM-14 is administered by subcutaneous injection with a microinfusion device given at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week .

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 100 kg and when the patients weigh more than 100 kg , they are dosed at 210 mg where AM-14 is administered by subcutaneous injection with a microinfusion device given at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week .

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg when the patients weigh less than or about 110 kg and when the patients weigh more than 110 kg , they are dosed at 210 mg where AM-14 is administered by subcutaneous injection with a microinfusion device given at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week .

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 90 kg and when the patients weigh more than 90 kg , they are dosed at 280 mg where AM-14 is administered by subcutaneous injection with a microinfusion device given at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week .

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 100 kg and when the patients weigh more than 100 kg , they are dosed at 280 mg where AM-14 is administered by subcutaneous injection with a microinfusion device given at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week .

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v

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L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered a dose of 140 mg when patients weigh less than or approximately equal to 110 kg, and when patients weigh more than 110 kg, they are administered a dose of 280 mg, where AM-14 is administered by subcutaneous injection using a microinfusion device conducted at time 0 ( first injection), one week after time 0, and then every two weeks after the first week of administration.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients having psoriasis, in particular plaque psoriasis, wherein said patients are dosed at 280 mg when the patients weigh less than or approximately equal to 90 kg and when the patients weigh more than 90 kg , they are dosed at 210 mg where AM-14 is administered by subcutaneous injection with a microinfusion device given at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week .

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered by subcutaneous injection using a microinfusion device at a dose of 280 mg at time 0 (first administration), through one week after time 0 and every four weeks when the weight of patients is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are dosed with 210 mg at time 0 (first administration), one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered by subcutaneous injection using a microinfusion device at a dose of 280 mg at time 0 (first administration), through one week after time 0 and every four weeks when patients weigh less than or approximately equal to 110 kg, and when patients weigh more than 110 kg, they are dosed with 210 mg at time 0 (first administration), one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered by subcutaneous injection using a microinfusion device at a dose of 280 mg at time 0 (first administration), through one week after time 0 and every four weeks when patients weigh less than or approximately equal to 90 kg, and when patients weigh more than 90 kg, they are dosed with 280 mg at time 0 (first administration), one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered by subcutaneous injection using a microinfusion device at a dose of 280 mg at time 0 (first administration), through one week after time 0 and every four weeks when the weight of patients is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are dosed with 280 mg at time 0 (first administration), one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat psoriasis in adult and/or juvenile patients with psoriasis, in particular plaque psoriasis, where said patients are administered by subcutaneous injection using a microinfusion device at a dose of 280 mg at time 0 (first administration), through one week after time 0 and every four weeks when patients weigh less than or approximately equal to 110 kg, and when patients weigh more than 110 kg, they are dosed with 280 mg at time 0 (first administration), one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are given a dose of 140 mg when the patients weigh less than or approximately equal to 90 kg every two weeks, and when patients weigh more than 90 kg, they are given a dose of 210 mg every two weeks.

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AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg every two weeks when the patient's weight is less than or approximately equal to 100 kg, and when patients weigh more than 100 kg, they are given a dose of 210 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 140 mg every two weeks when the patient's weight is less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are given a dose of 210 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 140 mg every two weeks when the patient's weight is less than or approximately equal to 90 kg, and when the weight of patients exceeds 90 kg, they are given a dose of 280 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg every two weeks when the patient's weight is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are given a dose of 280 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 140 mg every two weeks when the patient's weight is less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are given a dose of 280 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 280 mg every four weeks when the patient's weight is less than or approximately equal to 90 kg, and when patients weigh more than 90 kg, they are given a dose of 210 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 280 mg every four weeks when the patient's weight is less than or approximately equal to 100 kg, and when patients weigh more than 100 kg, they are given a dose of 210 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 280 mg every four weeks when the patient's weight is less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are given a dose of 210 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 280 mg every four weeks when the patient's weight is less than or approximately equal to 90 kg, and when the weight of patients exceeds 90 kg, they are given a dose of 280 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 280 mg every four weeks when the patient's weight is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are given a dose of 280 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v

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L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed

280 mg every four weeks when patients weigh less than or approximately equal to 110 kg, and when patients weigh more than 110 kg, they are given a dose of 280 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg by subcutaneous injection when the patients weigh less than or approximately 90 kg every two weeks, and when the weight of patients exceeds 90 kg, they are given a dose of 210 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 140 mg by subcutaneous injection every two weeks when the patient's weight is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are administered a dose of 210 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 140 mg by subcutaneous injection every two weeks when the patient's weight is less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are administered a dose of 210 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg by subcutaneous injection every two weeks when the patients are under or under weight. approximately equal to 90 kg, and when the weight of patients exceeds 90 kg, they are administered a dose of 280 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 140 mg by subcutaneous injection every two weeks when the patient's weight is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are administered a dose of 280 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg by subcutaneous injection every two weeks when the patients are under or under weight. approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are given a dose of 280 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 280 mg by subcutaneous injection every four weeks when the patient's weight is less than or approximately equal to 90 kg, and when the weight of patients exceeds 90 kg, they are given a dose of 210 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 280 mg by subcutaneous injection every four weeks when the patient's weight is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are administered a dose of 210 mg by subcutaneous injection every two weeks.

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AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 280 mg by subcutaneous injection every four weeks when the patient's weight is less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are administered a dose of 210 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 280 mg by subcutaneous injection every four weeks when the patient's weight is less than or approximately equal to 90 kg, and when the weight of patients exceeds 90 kg, they are administered a dose of 280 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 280 mg by subcutaneous injection every four weeks when the patient's weight is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are administered a dose of 280 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 280 mg by subcutaneous injection every four weeks when the patient's weight is less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are given a dose of 280 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are administered a dose of 140 mg delivered by subcutaneous injection with a self-injection syringe when the patient's weight is less than or approximately equal to 90 kg every two weeks, and when the weight of patients exceeds 90 kg, they are administered a dose of 210 mg, delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 140 mg delivered by subcutaneous injection with a self-injection syringe every two weeks when the weight of the patients is less than or approximately equal to 100 kg, and when the weight of the patients exceeds 100 kg, they are administered a dose of 210 mg delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 140 mg delivered by subcutaneous injection with a self-injection syringe every two weeks when the weight of the patients is less than or approximately equal to 110 kg, and when the weight of the patients exceeds 110 kg, they are administered a dose of 210 mg delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 140 mg delivered by subcutaneous injection with a self-injection syringe every two weeks when the weight of the patients is less than or approximately equal to 90 kg, and when the weight of the patients exceeds 90 kg, they are administered a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v

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L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are given a dose of 140 mg delivered by subcutaneous injection with a self-injection syringe every two weeks when the patients weigh less than or approximately equal to 100 kg, and when the patients weigh more than 100 kg they are given a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 140 mg delivered by subcutaneous injection with a self-injection syringe every two weeks when the weight of the patients is less than or approximately equal to 110 kg, and when the weight of the patients exceeds 110 kg, they are administered a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every four weeks when the weight of the patients is less than or approximately equal to 90 kg, and when the weight of the patients exceeds 90 kg, they are administered a dose of 210 mg delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every four weeks when the weight of the patients is less than or approximately equal to 100 kg, and when the weight of the patients exceeds 100 kg, they are administered a dose of 210 mg delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every four weeks when the weight of the patients is less than or approximately equal to 110 kg, and when the weight of the patients exceeds 110 kg, they are administered a dose of 210 mg delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every four weeks when the weight of the patients is less than or approximately equal to 90 kg, and when the weight of the patients exceeds 90 kg, they are administered a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every four weeks when the weight of the patients is less than or approximately equal to 100 kg, and when the weight of the patients exceeds 100 kg, they are administered a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every four weeks when patients weigh less than or approximately equal to 110 kg, and when patients weigh more than 110 kg, they are given a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 140 mg delivered by subcutaneous injection using a microinfusion device when weight patients is less than or approximately equal to 90 kg every two weeks, and when the weight of patients exceeds 90 kg, they are administered a dose of 210 mg, delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 140 mg delivered by subcutaneous injection using a microinfusion device every two weeks when the weight of patients is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are administered a dose of 210 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 140 mg delivered by subcutaneous injection using a microinfusion device every two weeks when the weight of patients is less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are administered a dose of 210 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 140 mg delivered by subcutaneous injection using a microinfusion device every two weeks when the weight of patients is less than or approximately equal to 90 kg, and when the weight of patients exceeds 90 kg, they are administered a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 140 mg delivered by subcutaneous injection using a microinfusion device every two weeks when the weight of patients is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are administered a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 140 mg delivered by subcutaneous injection using a microinfusion device every two weeks when the weight of patients is less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are administered a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every four weeks when the weight of patients is less than or approximately equal to 90 kg, and when the weight of patients exceeds 90 kg, they are administered a dose of 210 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed

280 mg delivered by subcutaneous injection using a microinfusion device every four weeks when patients weigh less than or approximately equal to 100 kg, and when patients weigh more than 100 kg, they are given a dose of 210 mg delivered by subcutaneous injection using a microinfusion device microinfusion every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every four weeks when the weight of patients is less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are administered a dose of 210 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every four weeks when the weight of patients is less than or approximately equal to 90 kg, and when the weight of patients exceeds 90 kg, they are administered a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every four weeks when the weight of patients is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are administered a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every four weeks when the weight of patients is less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are administered a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 90 kg, and when the weight of patients exceeds 90 kg, they are dosed with 210 mg, where AM-14 is administered by subcutaneous injection at time 0 (first administration), one week after time 0, and then every two weeks after administration at first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 100 kg, and when patients weigh more than 100 kg, they are dosed with 210 mg, where AM-14 is administered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then every two weeks after administration at first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are given a dose of 210 mg, where AM-14 is administered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then every two weeks after administration at first week.

- 55 040869

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 90 kg, and when the weight of patients exceeds 90 kg, they are dosed with 280 mg, where AM-14 is administered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then every two weeks after administration at first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are dosed with 280 mg, where AM-14 is administered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then every two weeks after administration at first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 110 kg, and when patients weigh more than 110 kg, they are dosed with 280 mg, where AM-14 is administered by subcutaneous injection given at time 0 (first administration), one week after time 0, and then every two weeks after administration at first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 280 mg when the patients weigh less than or approximately equal to 90 kg, and when the weight of patients exceeds 90 kg, they are dosed with 210 mg, where AM-14 is administered by subcutaneous injection at time 0 (first administration), one week after time 0, and then every two weeks after administration at first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 280 mg at time 0 (first administration), one week after time 0 and every four weeks when the weight of patients is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are dosed with 210 mg at time 0 (first administration), one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 280 mg at time 0 (first administration), one week after time 0 and every four weeks when the weight of patients is less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are dosed with 210 mg at time 0 (first administration), one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 280 mg at time 0 (first administration), one week after time 0 and every four weeks when patients weigh less than or approximately equal to 90 kg, and when patients weigh more than 90 kg, they are dosed with 280 mg at time 0 (first administration), one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 280 mg at time 0 (first administration), one week after time 0 and every

- 56 040869 four weeks when the patient's weight is less than or approximately equal to

100 kg, and when the weight of patients exceeds 100 kg, they are dosed with 280 mg at time 0 (first administration), one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are dosed at 280 mg at time 0 (first administration), one week after time 0 and every four weeks when the weight of patients is less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are dosed with 280 mg at time 0 (first administration), one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 90 kg, and when patients weigh more than 90 kg, they are given a dose of 210 mg, where AM-14 is administered by subcutaneous injection with a self-injection syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are administered a dose of 210 mg, where AM-14 is administered by subcutaneous injection with a self-injection syringe, carried out at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 110 kg, and when patients weigh more than 110 kg, they are given a dose of 210 mg, where AM-14 is administered by subcutaneous injection with a self-injection syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 90 kg, and when patients weigh more than 90 kg, they are given a dose of 280 mg, where AM-14 is administered by subcutaneous injection with a self-injection syringe given at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are administered a dose of 280 mg, where AM-14 is administered by subcutaneous injection with a self-injection syringe, carried out at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are administered a dose of 280 mg, where AM-14 is administered by subcutaneous injection with a self-injection syringe, carried out at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 280 mg when the patient's weight is less than or approximately equal to 90 kg, and when the weight of patients exceeds 90 kg, they are administered a dose of 210 mg, where AM-14 is administered by subcutaneous injection with a syringe for self-injection, carried out at time 0 (first administration), one week after time 0, and then carried out every two weeks after the introduction in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are administered by subcutaneous injection with a self-injecting syringe at a dose of 280 mg at time 0 (first administration), one week after time 0 and every four weeks when the weight of patients is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are dosed with 210 mg at time 0 (first administration), after one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are administered by subcutaneous injection with a self-injecting syringe at a dose of 280 mg at time 0 (first administration), one week after time 0 and every four weeks, when the weight of patients is less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are dosed with 210 mg at time 0 (first administration), after one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are administered by subcutaneous injection with a self-injecting syringe at a dose of 280 mg at time 0 (first administration), one week after time 0 and every four weeks when the weight of patients is less than or approximately equal to 90 kg, and when the weight of patients exceeds 90 kg, they are dosed with 280 mg at time 0 (first administration), after one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are administered by subcutaneous injection with a self-injecting syringe at a dose of 280 mg at time 0 (first administration), one week after time 0 and every four weeks when the weight of patients is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are dosed with 280 mg at time 0 (first administration), through one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are administered by subcutaneous injection with a self-injecting syringe at a dose of 280 mg at time 0 (first administration), one week after time 0 and every four weeks, when the weight of patients is less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are dosed with 280 mg at time 0 (first administration), after one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 90 kg, and when patients weigh more than 90 kg, they are dosed with 210 mg, where AM-14 is administered by subcutaneous injection using a microinfusion device, given at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2, can be used to treat adults and / or juvenile

- 58 040869 patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are given a dose of 140 mg when the patients weigh less than or approximately equal to 100 kg and when the patients weigh more than 100 kg , they are dosed at 210 mg where AM-14 is administered by subcutaneous injection with a microinfusion device given at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week .

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are dosed with 210 mg, where AM-14 is administered by subcutaneous injection using a microinfusion device, given at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 90 kg, and when the weight of patients exceeds 90 kg, they are dosed with 280 mg, where AM-14 is administered by subcutaneous injection using a microinfusion device, given at time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are dosed with 280 mg, where AM-14 is administered by subcutaneous injection using a microinfusion device, given at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are administered a dose of 280 mg, where AM-14 is administered by subcutaneous injection using a microinfusion device, given at time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, wherein said patients are dosed at 280 mg when the patients weigh less than or approximately equal to 90 kg, and when the weight of patients exceeds 90 kg, they are administered a dose of 210 mg, where AM-14 is administered by subcutaneous injection using a microinfusion device, carried out at time 0 (first injection), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are administered by subcutaneous injection using a microinfusion device at a dose of 280 mg at time 0 (first administration), one week after time 0 and every four weeks when the weight of patients is less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are dosed with 210 mg at time 0 (first administration) , one week after time 0, and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are administered by subcutaneous injection using a microinfusion device at a dose of 280 mg at time 0 (first administration), one week after time 0 and every four weeks when

- 59 040869 the weight of patients is less than or approximately equal to 110 kg, and when the weight of patients exceeds

110 kg, they are dosed with 210 mg at time 0 (first administration), one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are administered by subcutaneous injection using a microinfusion device at a dose of 280 mg at time 0 (first administration), one week after time 0 and every four weeks when patients weigh less than or approximately equal to 90 kg, and when patients weigh more than 90 kg, they are dosed with 280 mg at time 0 (first administration) , one week after time 0, and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are administered by subcutaneous injection using a microinfusion device at a dose of 280 mg at time 0 (first administration), one week after time 0 and every four weeks when patients weigh less than or approximately equal to 100 kg, and when patients weigh more than 100 kg, they are dosed with 280 mg at time 0 (first administration) , one week after time 0, and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, where said patients are administered by subcutaneous injection using a microinfusion device at a dose of 280 mg at time 0 (first administration), one week after time 0 and every four weeks when the weight of patients is less than or approximately equal to 110 kg, and when the weight of patients exceeds 110 kg, they are dosed with 280 mg at time 0 (first administration) , one week after time 0, and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) wherein said patients are dosed at 140 mg when the weight of the patients is less than or approximately equal to 90 kg every two weeks, and when the weight of the patients is greater than 90 kg, they are dosed at 210 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) wherein said patients are dosed with 140 mg every two weeks when the weight of the patients is less than or approximately equal to 100 kg, and when the weight of the patients is over 100 kg they are dosed with 210 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed at 140 mg every two weeks when the weight of the patients is less than or approximately equal to 110 kg and when the weight of the patients is greater than 110 kg they are dosed at 210 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) where said patients are dosed at 140 mg every two weeks when the weight of the patients is less than or approximately equal to 90 kg and when the weight of the patients is greater than 90 kg they are dosed at 280 mg every two

- 60 040869 weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed with 140 mg every two weeks when the weight of the patients is less than or approximately equal to 100 kg, and when the weight of the patients is over 100 kg they are dosed with 280 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed at 140 mg every two weeks when the weight of the patients is less than or approximately equal to 110 kg and when the weight of the patients is greater than 110 kg they are dosed at 280 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed with 280 mg every four weeks when the weight of the patients is less than or approximately equal to 90 kg, and when the weight of the patients is greater than 90 kg, they are dosed with 210 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed with 280 mg every four weeks when the weight of the patients is less than or approximately equal to 100 kg, and when the weight of the patients is greater than 100 kg, they are dosed with 210 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) wherein said patients are dosed with 280 mg every four weeks when the weight of the patients is less than or approximately equal to 110 kg, and when the weight of the patients is greater than 110 kg, they are dosed with 210 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) wherein said patients are dosed with 280 mg every four weeks when the weight of the patients is less than or approximately equal to 90 kg, and when the weight of the patients is greater than 90 kg, they are dosed with 280 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) where said patients are dosed with 280 mg every four weeks when the weight of the patients is less than or approximately equal to 100 kg, and when the weight of the patients exceeds 100 kg, they are dosed with 280 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporin, methotrexate, and PUVA (phototherapy with psoralen and ultraviolet light). radiation-A) wherein said patients are dosed with 280 mg every four weeks when the weight of the patients is less than or approximately equal to 110 kg, and when the weight of the patients is over 110 kg they are dosed with 280 mg every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed with 140 mg by subcutaneous injection when the patients weigh less than or approximately equal to 90 kg every two weeks, and when the patients weigh more than 90 kg they are dosed with 210 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed with 140 mg by subcutaneous injection every two weeks when the weight of the patients is less than or approximately equal to 100 kg, and when the weight of the patients is over 100 kg they are dosed with 210 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed with 140 mg by subcutaneous injection every two weeks when the patients weigh less than or approximately equal to 110 kg, and when the patients weigh more than 110 kg they are dosed with 210 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) wherein said patients are dosed with 140 mg by subcutaneous injection every two weeks when the weight of the patients is less than or approximately equal to 90 kg, and when the weight of the patients is over 90 kg they are dosed with 280 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) wherein said patients are dosed with 140 mg by subcutaneous injection every two weeks when the weight of the patients is less than or approximately equal to 100 kg, and when the weight of the patients is over 100 kg they are dosed with 280 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) wherein said patients are dosed with 140 mg by subcutaneous injection every two weeks when the weight of the patients is less than or approximately equal to 110 kg, and when the weight of the patients is over 110 kg they are dosed with 280 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) wherein said patients are dosed with 280 mg by subcutaneous injection every four weeks when the weight of the patients is less than or approximately equal to 90 kg, and when the weight of the patients is over 90 kg they are dosed with 210 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v

- 62 040869

L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen and ultraviolet-A phototherapy), wherein said patients are given a dose of 280 mg by subcutaneous injection every four weeks when the patients weigh less than or approximately equal to 100 kg, and when patients weigh more than 100 kg, they are given a dose of 210 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed with 280 mg by subcutaneous injection every four weeks when the patients weigh less than or approximately equal to 110 kg, and when the patients weigh more than 110 kg they are dosed with 210 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed with 280 mg by subcutaneous injection every four weeks when the weight of the patients is less than or approximately equal to 90 kg, and when the weight of the patients is over 90 kg they are dosed with 280 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) wherein said patients are dosed with 280 mg by subcutaneous injection every four weeks when the weight of the patients is less than or approximately equal to 100 kg, and when the weight of the patients is over 100 kg they are dosed with 280 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed with 280 mg by subcutaneous injection every four weeks when the weight of the patients is less than or approximately equal to 110 kg, and when the weight of the patients is over 110 kg they are dosed with 280 mg by subcutaneous injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are administered a dose of 140 mg delivered by subcutaneous injection with a self-injection syringe when the patients weigh less than or approximately equal to 90 kg every two weeks, and when the patients weigh more than 90 kg they are administered a dose of 210 mg delivered by subcutaneous injection syringe for self-injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) wherein said patients are administered a dose of 140 mg delivered by subcutaneous injection with a self-injection syringe every two weeks when the patients weigh less than or approximately equal to 100 kg, and when the patients weigh more than 100 kg they are administered a dose of 210 mg delivered by subcutaneous injection syringe for self-injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporin, methotrexate, and PUVA (phototherapy with psoralen and ultraviolet light). radiation-A), wherein said patients are given a dose of 140 mg, delivered by subcutaneous injection with a self-injection syringe every two weeks, when the patients weigh less than or approximately equal to 110 kg, and when the patients weigh more than 110 kg, they are given a dose of 210 mg, delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) wherein said patients are administered a dose of 140 mg delivered by subcutaneous injection with a self-injection syringe every two weeks when the patients weigh less than or approximately equal to 90 kg, and when the patients weigh more than 90 kg they are administered a dose of 280 mg delivered by subcutaneous injection syringe for self-injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are administered a dose of 140 mg delivered by subcutaneous injection with a self-injection syringe every two weeks when the patients weigh less than or approximately equal to 100 kg, and when the patients weigh more than 100 kg they are administered a dose of 280 mg delivered by subcutaneous injection syringe for self-injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are administered a dose of 140 mg delivered by subcutaneous injection with a self-injection syringe every two weeks when the patients weigh less than or approximately equal to 110 kg, and when the patients weigh more than 110 kg they are administered a dose of 280 mg delivered by subcutaneous injection syringe for self-injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) wherein said patients are administered a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every four weeks when the patients weigh less than or approximately equal to 90 kg, and when the patients weigh more than 90 kg they are administered a dose of 210 mg delivered by subcutaneous injection syringe for self-injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) wherein said patients are administered a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every four weeks when the patients weigh less than or approximately equal to 100 kg, and when the patients weigh more than 100 kg they are administered a dose of 210 mg delivered by subcutaneous injection syringe for self-injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3 w/v% -proline, 0.01 w/v% polysorbate 20, pH 4.8 ± 0.2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet-A light), wherein said patients are administered a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every four weeks when the patients weigh less than or approximately equal to 110 kg, and when the patients weigh more than 110 kg they are administered a dose of 210 mg delivered by subcutaneous injection with a syringe for self-injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (phototherapy with psoralen and ultraviolet light). radiation-A), wherein said patients are given a dose of 280 mg, delivered by subcutaneous injection with a self-injection syringe every four weeks, when the patients weigh less than or approximately equal to 90 kg, and when the patients weigh more than 90 kg, they are given a dose of 280 mg, delivered by subcutaneous injection with a self-injection syringe every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are administered a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every four weeks when the patients weigh less than or approximately equal to 100 kg, and when the patients weigh more than 100 kg they are administered a dose of 280 mg delivered by subcutaneous injection syringe for self-injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are administered a dose of 280 mg delivered by subcutaneous injection with a self-injection syringe every four weeks when the patients weigh less than or approximately equal to 110 kg, and when the patients weigh more than 110 kg they are administered a dose of 280 mg delivered by subcutaneous injection syringe for self-injection every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) wherein said patients are administered a dose of 140 mg delivered by subcutaneous injection using a microinfusion device when the patients weigh less than or approximately equal to 90 kg every two weeks, and when the patients weigh more than 90 kg they are administered a dose of 210 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed with 140 mg delivered by subcutaneous injection using a microinfusion device every two weeks when the patients weigh less than or approximately equal to 100 kg, and when the patients weigh more than 100 kg they are dosed with 210 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are given a dose of 140 mg delivered by subcutaneous injection using a microinfusion device every two weeks when the patients weigh less than or approximately equal to 110 kg and when the patients weigh more than 110 kg they are given a dose of 210 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are given a dose of 140 mg delivered by subcutaneous injection using a microinfusion device every two weeks when the patients weigh less than or approximately equal to 90 kg, and when the patients weigh more than 90 kg they are given a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

- 65 040869

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) wherein said patients are given a dose of 140 mg delivered by subcutaneous injection using a microinfusion device every two weeks when the patients weigh less than or approximately equal to 100 kg and when the patients weigh more than 100 kg they are given a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are given a dose of 140 mg delivered by subcutaneous injection using a microinfusion device every two weeks when the patients weigh less than or approximately equal to 110 kg, and when the patients weigh more than 110 kg they are given a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are administered a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every four weeks when the patients weigh less than or approximately equal to 90 kg, and when the patients weigh more than 90 kg they are administered a dose of 210 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed with 280 mg delivered by subcutaneous injection using a microinfusion device every four weeks when the weight of the patients is less than or approximately equal to 100 kg, and when the weight of the patients is over 100 kg they are dosed with 210 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed with 280 mg delivered by subcutaneous injection using a microinfusion device every four weeks when the patients weigh less than or approximately equal to 110 kg and when the patients weigh more than 110 kg they are dosed with 210 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are administered a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every four weeks when the patients weigh less than or approximately equal to 90 kg, and when the patients weigh more than 90 kg they are administered a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) wherein said patients are administered a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every four weeks when the patients weigh less than or approximately

- 66 040869 is 100 kg, and when the weight of patients exceeds 100 kg, they are administered a dose of 280 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) wherein said patients are dosed with 280 mg delivered by subcutaneous injection using a microinfusion device every four weeks when the patients weigh less than or approximately equal to 110 kg and when the patients weigh more than 110 kg they are dosed with 280 mg delivered by subcutaneous injection using a microinfusion device every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) where said patients are dosed with 140 mg when the weight of the patients is less than or approximately equal to 90 kg, and when the weight of the patients is greater than 90 kg, they are dosed with 210 mg, where AM-14 is administered by subcutaneous injection conducted at time 0 ( first injection), one week after time 0, and then every two weeks after the first week of administration.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) where said patients are dosed at 140 mg when the weight of the patients is less than or approximately equal to 100 kg, and when the weight of the patients is greater than 100 kg, they are dosed at 210 mg, where AM-14 is administered by subcutaneous injection conducted at time 0 ( first injection), one week after time 0, and then every two weeks after the first week of administration.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) where said patients are dosed with 140 mg when the weight of the patients is less than or approximately equal to 110 kg, and when the weight of the patients exceeds 110 kg, they are dosed with 210 mg, where AM-14 is administered by subcutaneous injection conducted at time 0 ( first injection), one week after time 0, and then every two weeks after the first week of administration.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) where said patients are dosed at 140 mg when the weight of the patients is less than or approximately equal to 90 kg, and when the weight of the patients is greater than 90 kg, they are dosed at 280 mg, where AM-14 is administered by subcutaneous injection conducted at time 0 ( first injection), one week after time 0, and then every two weeks after the first week of administration.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) where said patients are dosed with 140 mg when the weight of the patients is less than or approximately equal to 100 kg, and when the weight of the patients exceeds 100 kg, they are dosed with 280 mg, where AM-14 is administered by subcutaneous injection conducted at time 0 ( first injection), one week after time 0, and then every two weeks after the first week of administration.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who do not

- 67 040869 respond, have contraindications or do not tolerate other systemic therapies, including cyclosporine, methotrexate, and PUVA (phototherapy with psoralen and ultraviolet radiation-A), where said patients are administered a dose of 140 mg when the weight of patients is less than or approximately equal to 110 kg, and when patients weigh more than 110 kg, they are dosed with 280 mg, where AM-14 is administered by subcutaneous injection at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) where said patients are dosed with 280 mg when the weight of the patients is less than or approximately equal to 90 kg, and when the weight of the patients is greater than 90 kg, they are dosed with 210 mg, where AM-14 is administered by subcutaneous injection conducted at time 0 ( first injection), one week after time 0, and then every two weeks after the first week of administration.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed with 280 mg at time 0 (first administration), one week after time 0, and every four weeks when the patients weigh less than or approximately 100 kg, and when the patients weigh more than 100 kg, they a dose of 210 mg is administered at time 0 (first administration), one week after time 0, and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed with 280 mg at time 0 (first administration), one week after time 0, and every four weeks when the patients weigh less than or approximately equal to 110 kg, and when the patients weigh more than 110 kg, they a dose of 210 mg is administered at time 0 (first administration), one week after time 0, and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed with 280 mg at time 0 (first administration), one week after time 0 and every four weeks when the patients weigh less than or approximately equal to 90 kg, and when the patients weigh more than 90 kg, they a dose of 280 mg is administered at time 0 (first administration), one week after time 0, and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed with 280 mg at time 0 (first administration), one week after time 0, and every four weeks when the patients weigh less than or approximately 100 kg, and when the patients weigh more than 100 kg, they a dose of 280 mg is administered at time 0 (first administration), one week after time 0, and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed with 280 mg at time 0 (first administration), one week after time 0, and every four weeks when the patients weigh less than or approximately equal to 110 kg, and when the patients weigh more than 110 kg, they administer a dose of 280 mg at time

- 68 040869 (first administration), one week after time 0 and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 90 kg, and when the patients weigh more than 90 kg they are dosed at 210 mg, wherein AM-14 is administered by subcutaneous injection with a self-injection syringe administered at the time time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 100 kg, and when the patients weigh more than 100 kg they are dosed at 210 mg, wherein AM-14 is administered by subcutaneous injection with a self-injection syringe administered at the time time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 110 kg and when the patients weigh more than 110 kg they are dosed at 210 mg, wherein AM-14 is administered by subcutaneous injection with a self-injection syringe administered at the time time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 90 kg, and when the patients weigh more than 90 kg they are dosed at 280 mg, wherein AM-14 is administered by subcutaneous injection with a self-injection syringe administered at the time time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 100 kg, and when the patients weigh more than 100 kg they are dosed at 280 mg, wherein AM-14 is administered by subcutaneous injection with a self-injection syringe administered at the time time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 110 kg, and when the patients weigh more than 110 kg they are dosed at 280 mg, wherein AM-14 is administered by subcutaneous injection with a self-injection syringe administered at the time time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration.

- 69 040869

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are dosed at 280 mg when the patients weigh less than or approximately equal to 90 kg, and when the patients weigh more than 90 kg they are dosed at 210 mg, wherein AM-14 is administered by subcutaneous injection with a self-injection syringe administered at the time time 0 (first injection), one week after time 0, and then every two weeks after the first week of administration.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are administered by subcutaneous injection with a self-injecting syringe at a dose of 280 mg at time 0 (first administration), one week after time 0 and every four weeks when the patients weigh less than or approximately equal to 100 kg, and when patients weighing over 100 kg are dosed with 210 mg at time 0 (first administration), one week after time 0, and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are administered by subcutaneous injection with a self-injecting syringe at a dose of 280 mg at time 0 (first administration), one week after time 0, and every four weeks when the patients' weight is less than or approximately equal to 110 kg, and when the weight patients exceed 110 kg, they are given a dose of 210 mg at time 0 (first administration), one week after time 0, and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are administered by subcutaneous injection with a self-injecting syringe at a dose of 280 mg at time 0 (first administration), one week after time 0 and every four weeks when the patients weigh less than or approximately equal to 90 kg, and when patients weighing over 90 kg are dosed with 280 mg at time 0 (first administration), one week after time 0, and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are administered by subcutaneous injection with a self-injecting syringe at a dose of 280 mg at time 0 (first administration), one week after time 0 and every four weeks when the patients weigh less than or approximately equal to 100 kg, and when patients weighing over 100 kg are dosed with 280 mg at time 0 (first administration), one week after time 0, and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are administered by subcutaneous injection with a self-injecting syringe at a dose of 280 mg at time 0 (first administration), one week after time 0 and every four weeks when the patients weigh less than or approximately equal to 110 kg, and when patients weighing more than 110 kg are dosed with 280 mg at time 0 (first administration), one week after time 0, and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v

- 70 040869

L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, can be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy and ultraviolet-A) where said patients are given a dose of 140 mg when the patients weigh less than or approximately equal to 90 kg and when the patients weigh more than 90 kg, they are dosed at 210 mg where AM-14 is administered by subcutaneous injection with a microinfusion device given at time 0 (first injection), one week after time 0, and then every two weeks after administration at the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) where said patients are dosed at 140 mg when the weight of the patients is less than or approximately equal to 100 kg, and when the weight of the patients is greater than 100 kg, they are dosed at 210 mg, where AM-14 is administered by subcutaneous injection using a microinfusion device administered at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) where said patients are dosed at 140 mg when the weight of the patients is less than or approximately equal to 110 kg, and when the weight of the patients is greater than 110 kg, they are dosed at 210 mg, where AM-14 is administered by subcutaneous injection using a microinfusion device administered at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) where said patients are dosed at 140 mg when the weight of the patients is less than or approximately equal to 90 kg, and when the weight of the patients is greater than 90 kg, they are dosed at 280 mg, where AM-14 is administered by subcutaneous injection using a microinfusion device conducted at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) where said patients are dosed at 140 mg when the patients weigh less than or approximately equal to 100 kg, and when the patients weigh more than 100 kg they are dosed at 280 mg, where AM-14 is administered by subcutaneous injection using a microinfusion device administered at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) where said patients are dosed at 140 mg when the weight of the patients is less than or approximately equal to 110 kg, and when the weight of the patients is greater than 110 kg, they are dosed at 280 mg, where AM-14 is administered by subcutaneous injection using a microinfusion device administered at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2, can be used to treat adults and / or juvenile

- 71 040869 patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A), where said patients are administered a dose of 280 mg when the weight of patients is less than or approximately equal to 90 kg, and when the weight of patients exceeds 90 kg, they are administered a dose of 210 mg, where AM-14 is administered by subcutaneous injection using a microinfusion device conducted at time 0 (first administration ), one week after time 0, and then every two weeks after administration in the first week.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen phototherapy with ultraviolet light-A) wherein said patients are administered by subcutaneous injection using a microinfusion device at a dose of 280 mg at time 0 (first administration), one week after time 0, and every four weeks when the patients weigh less than or approximately equal to 100 kg, and when patients weigh more than 100 kg, they are dosed with 210 mg at time 0 (first administration), one week after time 0, and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are administered by subcutaneous injection using a microinfusion device at a dose of 280 mg at time 0 (first administration), one week after time 0, and every four weeks when the patients weigh less than or approximately equal to 110 kg, and when patients weigh more than 110 kg, they are dosed with 210 mg at time 0 (first administration), one week after time 0, and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are administered by subcutaneous injection using a microinfusion device at a dose of 280 mg at time 0 (first administration), one week after time 0, and every four weeks when the patients weigh less than or approximately equal to 90 kg, and when patients weigh more than 90 kg, they are dosed with 280 mg at time 0 (first administration), one week after time 0, and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are administered by subcutaneous injection using a microinfusion device at a dose of 280 mg at time 0 (first administration), one week after time 0, and every four weeks when the patients weigh less than or approximately equal to 100 kg, and when the weight of patients exceeds 100 kg, they are dosed with 280 mg at time 0 (first administration), one week after time 0, and every two weeks.

AM-14 in a formulation containing 140 mg/ml AM-14, 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be used to treat adult and/or juvenile patients with moderate to severe chronic plaque psoriasis who are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and PUVA (psoralen ultraviolet-A phototherapy) wherein said patients are administered by subcutaneous injection using a microinfusion device at a dose of 280 mg at time 0 (first administration), one week after time 0, and every four weeks when the patients weigh less than or approximately equal to 110 kg, and when patients weigh more than 110 kg, they are dosed with 280 mg at time 0 (first administration), one week after time 0, and every two weeks.

Administration and dosing regimens of AM-14 formulations can be adjusted to provide an effective amount for optimal therapeutic response. For example, a single bolus may be administered, several divided doses may be administered over a period of time, or the doses may be spaced apart.

- 72 040869 rationally reduce or increase if there are indications, depending on the need in a given therapeutic situation. AM-14 can be formulated for subcutaneous, intravenous, parenteral, intradermal, intramuscular, and/or intraperitoneal administration in unit dosage form for ease of administration and dosage uniformity. AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4.8 ± 0.2, can be obtained for subcutaneous, intravenous, parenteral, intradermal, intramuscular and/or intraperitoneal administration in unit dosage form for ease of administration and dosage uniformity. Dosing unit refers to a physically discrete amount of AM-14 suitable as a unit dosage for individuals to be treated; wherein each unit contains a predetermined amount of the active biopharmaceutical calculated to provide the desired therapeutic effect.

AM-14 formulations can be administered subcutaneously, intravenously, parenterally, intradermally, intramuscularly and/or intraperitoneally using standard methods. AM-14 can be administered subcutaneously, intravenously, parenterally, intradermally, intramuscularly, and/or intraperitoneally at the dosages described above and in the formulations described herein for the treatment of the diseases described above. AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4.8 ± 0.2, can be administered subcutaneously, intravenously , parenterally, intradermally, intramuscularly and/or intraperitoneally using standard methods at the dosages and dosing regimens described above for the treatment of psoriasis mentioned above. AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4.8 ± 0.2, can be administered subcutaneously, intravenously , intradermally and/or intramuscularly using standard methods at the dosages and dosing regimens described above, for the treatment of psoriasis mentioned above. AM-14 can be formulated at a concentration of approximately 140 mg/ml along with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4.8 ± 0 ,2, and can be administered subcutaneously, intravenously, intradermally and/or intramuscularly using standard methods at the dosages and dosing regimens described above for the treatment of psoriasis indicated above. AM-14 formulations such as AM-14 formulated with 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0, 2 may be administered more than once at scheduled intervals over a period of time. In certain embodiments, AM-14 formulations such as AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4, 8±0.2 administered over a period of at least a month or more. Embodiments include long-term treatment of the chronic conditions described above. Shorter periods of administration may be sufficient in the treatment of acute conditions, including, for example, from one to twenty-four weeks. Typically, AM-14 formulations are administered until the patient shows a medically meaningful improvement for the selected indicator or indicators from baseline, as judged by the medical professional. In particular, AM-14 formulations such as AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4.8 ±0.2, can be administered once every week or 6 to 8 days, or every two weeks or 12 to 16 days, or every three weeks or 19 to 23 days, or every month or 26 to 30 days, or every five weeks, or 33 to 34 days, or every six weeks, or 40 to 44 days, or every seven weeks, or 47 to 51 days, or every two months, or 54 to 58 days, subcutaneously, intravenously, parenterally, intradermally, intramuscularly and/or intraperitoneally at the dosages described above and in the formulations described herein for an indefinite period of time for the treatment of the diseases and conditions described above, in particular psoriasis.

Aspects of the invention include dosing regimens that further include a loading step. The loading step refers to the step of initially administering at least one dose of an AM-14 formulation to a patient by any of the routes described above and prior to administering the same or lower dose at any of the intervals and routes described above. The initial dose or doses rapidly increase the serum drug concentration to the effective target serum concentration. A loading dose or series of loading doses is administered 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and/or 14 days prior to the normal dosing course. It is understood that a day also includes any time interval between 1 and 24 hours. For example, as described in more detail above, AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 wt./vol.% polysorbate 20, pH 4.8±0.2, administered at time 0 (first injection), one week after time 0, and then administered every two weeks after administration in the first week.

It is understood that in the methods of treating diseases described herein, an effective amount of an AM-14 formulation such as AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 wt./vol.% polysorbate 20, pH 4.8±0.2. Depending on the indication for treatment, a therapeutically effective amount is sufficient to provide an improvement in at least one symptom of a given pathological condition at least

- 73 040869 approximately 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95% or more relative to individuals not exposed treatment.

Aspects of the invention also include methods for regulating gene expression in patients with psoriasis using AM-14. Example 3 details the genes that are regulated by AM-14. Thus, aspects of the invention include methods for regulating the genes presented in table. 3.1, 3.2 and/or 3.3 in patients with psoriasis by administering AM-14. Aspects of the invention include the use of AM-14 to obtain drugs for the regulation of the genes shown in table. 3.1, 3.2 and/or 3.3 in patients with psoriasis. Also, the methods of use include other aspects described in example 3, such as the temporal relationship between the introduction of AM-14 and the regulation of the gene, as well as the degree (eg, fold change) of the regulation of the gene and the introduction of AM-14.

Aspects of the invention also include methods for regulating gene expression in patients with psoriasis using AM-14 and simultaneously reducing the PASI score in a patient with psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95 or 100%. Example 3 details the genes that are regulated by AM-14. Thus, aspects of the invention include methods for regulating the genes presented in table. 3.1, 3.2 and/or 3.3, and at the same time reducing the PASI score in a patient with psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75 , 80, 85, 90, 95 or 100% by introducing AM-14. Aspects of the invention include the use of AM-14 to obtain a drug for the regulation of the genes presented in table. 3.1, 3.2 and/or 3.3, and at the same time reducing the PASI score in a patient with psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95 or 100%. Also, the methods of use contemplate additional aspects described in Example 3, such as the temporal relationship between AM-14 administration and gene regulation, as well as the degree (eg, fold change) of gene regulation and AM-14 administration.

Aspects of the invention also include methods for regulating gene expression for 15 days or less in patients with psoriasis using AM-14 and simultaneously reducing the PASI score in a patient with psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95 or 100%. Example 3 details the genes that are regulated by AM-14. Thus, aspects of the invention include methods for regulating the genes presented in table. 3.1, 3.2 and/or 3.3 for 15 days or less and at the same time reduce the PASI score in a patient with psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60 , 65, 70, 75, 80, 85, 90, 95, or 100% by administering AM-14. Aspects of the invention include the use of AM-14 to obtain a drug for the regulation of the genes presented in table. 3.1, 3.2 and/or 3.3 for 15 days or less and at the same time reduce the PASI score in a patient with psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60 , 65, 70, 75, 80, 85, 90, 95 or 100%. Also included in the methods of use are additional aspects described in Example 3, such as the temporal relationship between AM-14 administration and gene regulation, as well as the degree (eg, fold change) of gene regulation and AM-14 administration.

Aspects of the invention also include methods for regulating gene expression in patients with psoriasis using anti-IL-17 antagonist antibodies. An antagonist antibody against IL-17 is an antibody that inhibits activation by IL-17A or IL-17A/F of their recognition receptor(s), including IL-17RA, IL-17RC and IL-17RA/RC. Antagonist antibodies against IL-17 include antibodies against IL-17RA or antibodies against IL-17A and/or IL-17A/F. Example 3 details the genes that are regulated by the exemplary antibody AM-14. Thus, aspects of the invention include methods for regulating the genes shown in table. 3.1, 3.2 and/or 3.3 in patients with psoriasis by administering an antagonist antibody against IL-17. Aspects of the invention include the use of an antagonist antibody against IL-17 to obtain a drug for the regulation of the genes shown in table. 3.1, 3.2 and/or 3.3 in patients with psoriasis. Also included in the methods of use are other aspects described in Example 3, such as the temporal relationship between administration of the anti-IL-17 antagonist antibody and gene regulation, as well as the degree (e.g., fold change) of gene regulation and administration of the anti-IL-17 antagonist antibody.

Aspects of the invention also include methods for regulating gene expression and simultaneously reducing the PASI score in a patient with psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75 , 80, 85, 90, 95, or 100% in patients with psoriasis using anti-IL-17 antagonist antibodies. An antagonist antibody against IL-17 is an antibody that inhibits activation by IL-17A or IL-17A/F of their recognition receptor(s), including IL-17RA, IL-17RC and IL-17RA/RC. Antagonist antibodies against IL-17 include antibodies against IL-17RA or antibodies against IL-17A and/or IL-17A/F. Example 3 details the genes that are regulated by the exemplary antibody AM-14. Thus, aspects of the invention include methods for regulating the genes shown in table. 3.1, 3.2 and/or 3.3 and at the same time reducing the PASI score in a patient with psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80%, 85%, 90%, 95%, or 100% by administering an anti-IL-17 antagonist antibody. Aspects of the invention include the use of an anti-IL-17 antagonist antibody for the production of a gene regulatory drug, as shown in Table 1. 3.1, 3.2 and/or 3.3, and at the same time reducing the PASI score in a patient with psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75 , 80, 85, 90, 95 or 100% in patients with psoriasis. Also, the methods of use include additional aspects described in example 3, such as the temporal relationship between administration of the anti-IL-17 antagonist antibody and gene regulation, as well as the degree (e.g., fold change) of gene regulation and administration of the anti-IL-17 antagonist antibody.

Aspects of the invention also include methods for regulating gene expression for 15 days or less and simultaneously reducing the PASI score in a patient with psoriasis by at least 10, 15, 20, 25, 3θ, 35, 40, 45, 50, 55, 60 , 65, 70, 75, 80, 85, 90, 95, or 100% in patients with psoriasis using anti-IL-17 antagonist antibodies. An antagonist antibody against IL-17 is an antibody that inhibits activation by IL-17A or IL-17A/F of their recognition receptor(s), including IL-17RA, IL-17RC and IL-17RA/RC. Antagonist antibodies against IL-17 include antibodies against IL-17RA or antibodies against IL-17A and/or IL-17A/F. Example 3 details the genes that are regulated by the exemplary antibody AM-14. Thus, aspects of the invention include methods for regulating the genes shown in table. 3.1, 3.2 and/or 3.3 for 15 days or less and at the same time reduce the PASI score in a patient with psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60 , 65, 70, 75, 80, 85, 90, 95 or 100% in patients with psoriasis, by administration of an antagonist antibody against IL-17. Aspects of the invention include the use of an antagonist antibody against IL-17 to obtain a drug for the regulation of the genes shown in table. 3.1, 3.2 and/or 3.3 for 15 days or less and at the same time reduce the PASI score in a patient with psoriasis by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60 , 65, 70, 75, 80, 85, 90, 95 or 100%. Also, the methods of use include additional aspects described in example 3, such as the temporal relationship between administration of the anti-IL-17 antagonist antibody and gene regulation, as well as the degree (e.g., fold change) of gene regulation and administration of the anti-IL-17 antagonist antibody.

Embodiments of the invention include the embodiments described above and throughout the description, including the following.

1. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of about 70 to about 300 mg of antibody per dose, wherein said antibody contains a heavy chain CDR1, containing SEQ ID NO: 5, heavy chain CDR2 containing SEQ ID NO: 7, heavy chain CDR3 containing SEQ ID NO: 8, light chain CDR1 containing SEQ ID NO: 9, light chain CDR2 containing SEQ ID NO: 10 , and a light chain CDR3 comprising SEQ ID NO: 11, and wherein said antibody specifically binds human IL-17 A receptor.

2. The method of Embodiment 1 wherein the psoriasis is plaque psoriasis.

3. The method of Embodiment 2 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

4. The method of Embodiment 3 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

5. The method of Embodiment 3 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

6. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of approximately 70 mg of antibody per dose, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO : 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 a chain containing SEQ ID NO: 11 and wherein said antibody specifically binds human IL-17 A receptor.

7. The method according to embodiment 6 wherein the psoriasis is plaque psoriasis.

8. The method of Embodiment 6 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

9. The method of embodiment 8 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

10. The method of Embodiment 8 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein:

- 75 040869 Patients who do not respond, have a contraindication, or cannot tolerate other systemic therapies, including cyclosporine, methotrexate, and psoralen and ultraviolet-A phototherapy.

11. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of approximately 140 mg of antibody per dose, wherein said antibody contains a heavy chain CDR1 containing SEQ ID NO : 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 chain containing SEQ ID NO: 11, and where the specified antibody specifically binds the A receptor A IL-17 person.

12. The method according to embodiment 11 wherein the psoriasis is plaque psoriasis.

13. The method of embodiment 12 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

14. The method of embodiment 13 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

15. The method of Embodiment 13 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

16. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of approximately 210 mg of antibody per dose, wherein said antibody contains a heavy chain CDR1 containing SEQ ID NO : 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 a chain containing SEQ ID NO: 11 and wherein said antibody specifically binds human IL-17 A receptor.

17. The method of Embodiment 16 wherein the psoriasis is plaque psoriasis.

18. The method of Embodiment 17 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

19. The method of embodiment 18 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

20. The method of Embodiment 18, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

21. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of approximately 280 mg of antibody per dose, wherein said antibody contains a heavy chain CDR1 containing SEQ ID NO : 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 a chain containing SEQ ID NO: 11 and wherein said antibody specifically binds human IL-17 A receptor.

22. The method of Embodiment 21 wherein the psoriasis is plaque psoriasis.

23. The method of Embodiment 22 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

24. The method of embodiment 23 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

25. The method of Embodiment 23, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

26. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of from about 70 to about 300 mg of antibody for up to -

- 76 040869 zu, where the specified antibody or its binding IL-17RA fragment contains the sequence of the variable domain of the heavy chain, containing SEQ ID NO: 3, and the sequence of the variable domain of the light chain, containing SEQ ID NO: 4, and where the specified antibody specifically binds the receptor

A human IL-17.

27. The method of Embodiment 26 wherein the psoriasis is plaque psoriasis.

28. The method of Embodiment 27 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

29. The method of embodiment 28 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

30. The method of Embodiment 28, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

31. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of approximately 70 mg of antibody per dose, wherein said antibody or IL-17RA binding fragment thereof contains the sequence heavy chain variable domain sequence comprising SEQ ID NO: 3 and a light chain variable domain sequence comprising

SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 A receptor.

32. The method of Embodiment 31 wherein the psoriasis is plaque psoriasis.

33. The method of Embodiment 32 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

34. The method of embodiment 33 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

35. The method of Embodiment 33, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

36. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of approximately 140 mg of antibody per dose, wherein said antibody or IL-17RA binding fragment thereof contains the sequence heavy chain variable domain sequence comprising SEQ ID NO: 3 and a light chain variable domain sequence comprising

SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 A receptor.

37. The method of Embodiment 36 wherein the psoriasis is plaque psoriasis.

38. The method of Embodiment 36 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

39. The method of embodiment 38 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

40. The method of Embodiment 38, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

41. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of approximately 210 mg of antibody per dose, wherein said antibody or IL-17RA binding fragment thereof contains the sequence heavy chain variable domain sequence comprising SEQ ID NO: 3 and a light chain variable domain sequence comprising

SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 A receptor.

42. The method of Embodiment 41 wherein the psoriasis is plaque

- 77 040869 psoriasis.

43. The method of embodiment 42 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

44. The method of embodiment 43 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

45. The method of Embodiment 43, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

46. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of approximately 280 mg of antibody per dose, wherein said antibody or IL-17RA binding fragment thereof contains the sequence heavy chain variable domain sequence comprising SEQ ID NO: 3 and a light chain variable domain sequence comprising

SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 A receptor.

47. The method of Embodiment 46 wherein the psoriasis is plaque psoriasis.

48. The method of embodiment 47 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

49. The method of embodiment 48 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

50. The method of Embodiment 48, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

51. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of about 70 to about 300 mg of antibody per dose, wherein said antibody or its binding IL- The 17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1 and a light chain sequence containing SEQ ID NO: 2.

52. The method of Embodiment 51 wherein the psoriasis is plaque psoriasis.

53. The method of embodiment 52 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

54. The method of embodiment 53 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

55. The method of Embodiment 53, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

56. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of approximately 70 mg of antibody per dose, wherein said antibody or IL-17RA binding fragment thereof contains the sequence a heavy chain containing SEQ ID NO: 1 and a light chain sequence containing SEQ ID NO: 2.

57. The method of Embodiment 56 wherein the psoriasis is plaque psoriasis.

58. The method of embodiment 57 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

59. The method of embodiment 58 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

60. The method of Embodiment 58 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic methods

- 78 040869 therapies, including cyclosporine, methotrexate and phototherapy with psoralen and ultraviolet radiation-A.

61. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of approximately 140 mg of antibody per dose, wherein said antibody or IL-17RA binding fragment thereof contains the sequence a heavy chain containing SEQ ID NO: 1 and a light chain sequence containing SEQ ID NO: 2.

62. The method of Embodiment 61 wherein the psoriasis is plaque psoriasis.

63. The method of Embodiment 62 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

64. The method of embodiment 63 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

65. The method of Embodiment 63, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

66. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of approximately 210 mg of antibody per dose, wherein said antibody or IL-17RA binding fragment thereof contains the sequence a heavy chain containing SEQ ID NO: 1 and a light chain sequence containing SEQ ID NO: 2.

67. The method of Embodiment 66 wherein the psoriasis is plaque psoriasis.

68. The method of Embodiment 67 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

69. The method of embodiment 68 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

70. The method of Embodiment 68, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

71. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of approximately 280 mg of antibody per dose, wherein said antibody or IL-17RA binding fragment thereof contains the sequence a heavy chain containing SEQ ID NO: 1 and a light chain sequence containing SEQ ID NO: 2.

72. The method of Embodiment 71 wherein the psoriasis is plaque psoriasis.

73. The method of Embodiment 72 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

74. The method of embodiment 73 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

75. The method of Embodiment 73, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

76. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/mL of isolated antibody in a single or divided dose of about 70 to about 300 mg of antibody per dose, wherein said antibody contains a heavy chain CDR1 comprising SEQ ID NO: 5, CDR2 heavy chain CDR3 of SEQ ID NO: 7, heavy chain CDR3 of SEQ ID NO: 8, light chain CDR1 of SEQ ID NO: 9, light chain CDR2 of SEQ ID NO: 10, and light chain CDR3 of SEQ ID NO: 11, and wherein said antibody specifically binds human IL-17 A receptor.

- 79 040869

77. The method of Embodiment 76 wherein the psoriasis is plaque psoriasis.

78. The method of embodiment 77 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

79. The method of embodiment 78 wherein the moderate to severe plaque psoriasis is moderate to severe chronic plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

80. The method of Embodiment 78, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

81. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/ml of isolated antibody in a single or divided dose of approximately 70 mg of antibody per dose, wherein said antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, heavy chain CDR3 containing SEQ ID NO: 8, light chain CDR1 containing SEQ ID NO: 9, light chain CDR2 containing SEQ ID NO: 10, and light chain CDR3 containing SEQ ID NO: 11 , and wherein said antibody specifically binds human IL-17 receptor A.

82. The method of Embodiment 81 wherein the psoriasis is plaque psoriasis.

83. The method of Embodiment 82 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

84. The method of embodiment 83 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

85. The method of Embodiment 83, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

86. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/mL of isolated antibody in a single or divided dose of approximately 140 mg antibody per dose, wherein said antibody comprises a heavy chain CDR1 comprising SEQ ID NO: 5, a heavy chain CDR2 comprising SEQ ID NO: 7, heavy chain CDR3 containing SEQ ID NO: 8, light chain CDR1 containing SEQ ID NO: 9, light chain CDR2 containing SEQ ID NO: 10, and light chain CDR3 containing SEQ ID NO: 11 , and wherein said antibody specifically binds human IL-17 receptor A.

87. The method of Embodiment 86 wherein the psoriasis is plaque psoriasis.

88. The method of Embodiment 87 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

89. The method of embodiment 88 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

90. The method of Embodiment 88, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

91. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/ml of isolated antibody in a single or divided dose of approximately 210 mg of antibody per dose, wherein said antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, heavy chain CDR3 containing SEQ ID NO: 8, light chain CDR1 containing SEQ ID NO: 9, light chain CDR2 containing SEQ ID NO: 10, and light chain CDR3 containing SEQ ID NO: 11 , and wherein said antibody specifically binds human IL-17 receptor A.

92. The method of Embodiment 91 wherein the psoriasis is plaque

- 80 040869 psoriasis.

93. The method of embodiment 92 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

94. The method of embodiment 93 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

95. The method of Embodiment 93, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

96. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/mL of isolated antibody in a single or divided dose of approximately 280 mg of antibody per dose, wherein said antibody contains a heavy chain CDR1 comprising SEQ ID NO: 5, a heavy chain CDR2 comprising SEQ ID NO: 7, heavy chain CDR3 containing SEQ ID NO: 8, light chain CDR1 containing SEQ ID NO: 9, light chain CDR2 containing SEQ ID NO: 10, and light chain CDR3 containing SEQ ID NO: 11 , and wherein said antibody specifically binds human IL-17 receptor A.

97. The method of embodiment 96 wherein the psoriasis is plaque psoriasis.

98. The method of embodiment 97 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

99. The method of embodiment 98 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

100. The method of Embodiment 99, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

101. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/mL of isolated antibody in a single or divided dose of about 70 to about 300 mg of antibody per dose, wherein said antibody or IL-17RA binding fragment thereof contains a heavy chain variable domain sequence containing SEQ ID NO: 3 and a light chain variable domain sequence containing SEQ ID NO: 4, and wherein said antibody specifically binds the human IL-17 A receptor.

102. The method of embodiment 101 wherein the psoriasis is plaque psoriasis.

103. The method of embodiment 102 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

104. The method of embodiment 103 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

105. The method of embodiment 103, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

106. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/mL of isolated antibody in a single or divided dose of approximately 70 mg of antibody per dose, wherein said antibody or IL-17RA binding fragment thereof contains a heavy chain variable domain sequence comprising SEQ ID NO: 3, and a light chain variable domain sequence comprising SEQ ID NO: 4, and wherein said antibody specifically binds the human IL-17 A receptor.

107. The method of embodiment 106 wherein the psoriasis is plaque psoriasis.

108. The method of embodiment 107 wherein plaque psoriasis is

- 81 040869 moderate to severe plaque psoriasis.

109. The method of embodiment 108 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

110. The method of embodiment 108, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

111. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/mL of isolated antibody in a single or divided dose of approximately 140 mg antibody per dose, wherein said antibody or IL-17RA binding fragment thereof contains a heavy chain variable domain sequence comprising SEQ ID NO: 3, and a light chain variable domain sequence comprising SEQ ID NO: 4, and wherein said antibody specifically binds the human IL-17 A receptor.

112. The method of embodiment 111 wherein the psoriasis is plaque psoriasis.

113. The method of embodiment 112 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

114. The method of embodiment 113 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

115. The method of Embodiment 113, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

116. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/mL of isolated antibody in a single or divided dose of approximately 210 mg of antibody per dose, wherein said antibody or IL-17RA binding fragment thereof contains a heavy chain variable domain sequence comprising SEQ ID NO: 3, and a light chain variable domain sequence comprising SEQ ID NO: 4, and wherein said antibody specifically binds the human IL-17 A receptor.

117. The method of embodiment 116 wherein the psoriasis is plaque psoriasis.

118. The method of embodiment 117 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

119. The method of embodiment 118 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

120. The method of embodiment 118, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

121. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4.8±0.2, and 140 mg/mL of isolated antibody in a single or divided dose of approximately 280 mg of antibody per dose, wherein said antibody or IL-17RA binding fragment thereof contains a heavy chain variable domain sequence comprising SEQ ID NO: 3, and a light chain variable domain sequence comprising SEQ ID NO: 4, and wherein said antibody specifically binds the human IL-17 A receptor.

122. The method of embodiment 121 wherein the psoriasis is plaque psoriasis.

123. The method of embodiment 122 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

124. The method of embodiment 123 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

- 82 040869

125. The method of embodiment 123, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

126. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4.8 ± 0.2, and 140 mg/mL of isolated antibody in a single or divided dose of about 70 to about 300 mg of antibody per dose, wherein said antibody or IL-17RA binding fragment thereof contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

127. The method of embodiment 126 wherein the psoriasis is plaque psoriasis.

128. The method of embodiment 127 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

129. The method of embodiment 128 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

130. The method of embodiment 128, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

131. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml of isolated antibody in a single or divided dose of approximately 70 mg of antibody per dose, wherein said antibody or IL-17RA binding fragment thereof contains a heavy chain sequence comprising SEQ ID NO: 1 and a light chain sequence containing SEQ ID NO: 2.

132. The method of embodiment 131 wherein the psoriasis is plaque psoriasis.

133. The method of embodiment 132 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

134. The method of embodiment 133 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

135. The method of Embodiment 133, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

136. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v% polysorbate 20, pH 4.8±0.2, and 140 mg/mL of isolated antibody in a single or divided dose of approximately 140 mg antibody per dose, wherein said antibody or IL-17RA binding fragment thereof contains a heavy chain sequence comprising SEQ ID NO: 1 and a light chain sequence containing SEQ ID NO: 2.

137. The method of embodiment 136 wherein the psoriasis is plaque psoriasis.

138. The method of embodiment 137 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

139. The method of embodiment 138 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

140. The method of Embodiment 138, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

141. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, including

- 83 040869 teasing the introduction to the specified patient of a pharmaceutical composition containing 10 mm glutamic acid, 3 wt./vol.% L-proline, 0.01 wt./vol.% polysorbate 20, pH 4.8±0.2, and 140 mg/ml of isolated antibody in a single or divided dose of approximately 210 mg of antibody per dose, wherein said antibody or IL-17RA binding fragment thereof comprises a heavy chain sequence comprising SEQ ID NO: 1 and a light chain sequence comprising SEQ ID NO: 2 .

142. The method of embodiment 141 wherein the psoriasis is plaque psoriasis.

143. The method of embodiment 142 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

144. The method of embodiment 143 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

145. The method of Embodiment 143, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

146. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/ml of isolated antibody in a single or divided dose of approximately 280 mg of antibody per dose, wherein said antibody or IL-17RA binding fragment thereof contains a heavy chain sequence comprising SEQ ID NO: 1 and a light chain sequence containing SEQ ID NO: 2.

147. The method of embodiment 146 wherein the psoriasis is plaque psoriasis.

148. The method of embodiment 147 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

149. The method of embodiment 148 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

150. The method of embodiment 148, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

151. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of about 70 to about 300 mg of antibody per dose, conducted at time 0 (first administration ), one week after time 0, and then every two weeks after administration in the first week, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 a chain containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 containing SEQ ID NO: 11, and where the specified antibody specifically binds the receptor A human IL-17.

152. The method of embodiment 151 wherein the psoriasis is plaque psoriasis.

153. The method of embodiment 152 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

154. The method of embodiment 153 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

155. The method of Embodiment 153, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

156. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 70 mg per dose administered at time 0 (first administration), one week after time point 0, and then every two weeks after administration in the first week, where the specified antibody contains a heavy chain CDR1 containing

- 84 040869

SEQ ID NO: 5, Heavy chain CDR2 containing SEQ ID NO: 7, Heavy chain CDR3 containing

SEQ ID NO: 8, Light chain CDR1 containing SEQ ID NO: 9, Light chain CDR2 containing

SEQ ID NO: 10, and a light chain CDR3 comprising SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

157. The method of embodiment 156 wherein the psoriasis is plaque psoriasis.

158. The method of embodiment 157 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

159. The method of embodiment 158 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

160. The method of embodiment 158, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

161. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg per dose administered at time 0 (first administration), one week after time point 0, and then every two weeks after administration in the first week, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO : 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 receptor A.

162. The method of embodiment 161 wherein the psoriasis is plaque psoriasis.

163. The method of embodiment 162 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

164. The method of embodiment 163 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

165. The method of Embodiment 163, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

166. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 210 mg per dose administered at time 0 (first administration), one week after time point 0, and then every two weeks after administration in the first week, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO : 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 receptor A.

167. The method of embodiment 166 wherein the psoriasis is plaque psoriasis.

168. The method of embodiment 167 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

169. The method of embodiment 168 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

170. The method of embodiment 168, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

171. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 280 mg per dose administered at time 0 (first administration), one week after time point 0, and then carried out every two weeks after the introduction

- 85 040869 denium in the first week, where the specified antibody contains a heavy chain CDR1 containing

SEQ ID NO: 5, Heavy chain CDR2 containing SEQ ID NO: 7, Heavy chain CDR3 containing

SEQ ID NO: 8, Light chain CDR1 containing SEQ ID NO: 9, Light chain CDR2 containing

SEQ ID NO: 10, and a light chain CDR3 comprising SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

172. The method of embodiment 171 wherein the psoriasis is plaque psoriasis.

173. The method of embodiment 172 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

174. The method of embodiment 173 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

175. The method of Embodiment 173, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

176. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of about 70 to about 300 mg of antibody per dose, conducted at time 0 (first administration ), one week after time 0, and then every two weeks after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a variable domain sequence light chain containing SEQ ID NO: 4, and where the specified antibody specifically binds the receptor A of human IL-17.

177. The method of embodiment 176 wherein the psoriasis is plaque psoriasis.

178. The method of embodiment 177 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

179. The method of embodiment 178 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

180. The method of Embodiment 178, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

181. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 70 mg per dose administered at time 0 (first administration), one week after time point 0, and then every two weeks after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 receptor A.

182. The method of embodiment 181 wherein the psoriasis is plaque psoriasis.

183. The method of embodiment 182 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

184. The method of embodiment 183 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

185. The method of embodiment 183, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

186. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg per dose administered at time 0 (first administration), one week after time point 0, and then every two weeks after administration in the first week, where the specified antibody or its IL-17RA binding fragment contains

- 86 040869 a heavy chain variable domain sequence comprising SEQ ID NO: 3 and a light chain variable domain sequence comprising SEQ ID NO: 4, and wherein said antibody specifically binds the human IL-17 A receptor.

187. The method of embodiment 186 wherein the psoriasis is plaque psoriasis.

188. The method of embodiment 187 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

189. The method of embodiment 188 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

190. The method of embodiment 188, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

191. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 210 mg per dose administered at time 0 (first administration), one week after time point 0, and then every two weeks after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 receptor A.

192. The method of embodiment 191 wherein the psoriasis is plaque psoriasis.

193. The method of embodiment 192 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

194. The method of embodiment 193 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

195. The method of Embodiment 193, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

196. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 280 mg per dose administered at time 0 (first administration), one week after time point 0, and then every two weeks after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 receptor A.

197. The method of embodiment 196 wherein the psoriasis is plaque psoriasis.

198. The method of embodiment 197 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

199. The method of embodiment 198 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

200. The method of Embodiment 198, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

201. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of about 70 to about 300 mg of antibody per dose, conducted at time 0 (first administration ), one week after time 0, and then every two weeks after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

- 87 040869

202. The method of embodiment 201 wherein the psoriasis is plaque psoriasis.

203. The method of embodiment 202 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

204. The method of embodiment 203 wherein the moderate to severe plaque psoriasis is moderate to severe chronic plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

205. The method of embodiment 203, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

206. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 70 mg per dose administered at time 0 (first administration), one week after time point 0, and then every two weeks after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

207. The method of embodiment 206 wherein the psoriasis is plaque psoriasis.

208. The method of embodiment 207 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

209. The method of embodiment 208 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

210. The method of embodiment 208, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

211. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg per dose administered at time 0 (first administration), one week after time point 0, and then every two weeks after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

212. The method of embodiment 211 wherein the psoriasis is plaque psoriasis.

213. The method of embodiment 212 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

214. The method of embodiment 213 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

215. The method of embodiment 213, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

216. A method for the treatment of psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 210 mg per dose administered at time 0 (first administration), one week after time point 0, and then every two weeks after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

217. The method of embodiment 216 wherein the psoriasis is plaque psoriasis.

218. The method of embodiment 217 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

219. The method of embodiment 218 wherein plaque psoriasis is moderate to

- 88 040869 severe is moderate to severe chronic plaque psoriasis and these patients are candidates for systemic therapy or phototherapy.

220. The method of embodiment 218, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

221. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 280 mg per dose administered at time 0 (first administration), one week after time point 0, and then every two weeks after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

222. The method of embodiment 221 wherein the psoriasis is plaque psoriasis.

223. The method of embodiment 222 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

224. The method of embodiment 223 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

225. The method of embodiment 223, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

226. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of about 70 to about 300 mg of antibody per dose, conducted at time 0 (first administration ), one week after time point 0, and then once a month after administration in the first week, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 a chain containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 containing SEQ ID NO: 11, and where the specified antibody specifically binds the receptor A human IL-17.

227. The method of embodiment 226 wherein the psoriasis is plaque psoriasis.

228. The method of embodiment 227 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

229. The method of embodiment 228, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

230. The method of embodiment 228, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

231. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 70 mg per dose administered at time 0 (first administration), one week after time point 0, and then once a month after administration in the first week, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO : 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 receptor A.

232. The method of embodiment 231 wherein the psoriasis is plaque psoriasis.

233. The method of embodiment 232 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

234. The method of embodiment 233 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and is indicated by

- 89 040869 These patients are candidates for systemic therapy or phototherapy.

235. The method of embodiment 233, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

236. A method for the treatment of psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg per dose administered at time 0 (first administration), one week after time point 0, and then once a month after administration in the first week, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO : 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 receptor A.

237. The method of embodiment 236 wherein the psoriasis is plaque psoriasis.

238. The method of embodiment 237 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

239. The method of embodiment 238 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

240. The method of embodiment 238, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

241. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 210 mg per dose administered at time 0 (first administration), one week after time point 0, and then once a month after administration in the first week, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO : 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 receptor A.

242. The method of embodiment 241 wherein the psoriasis is plaque psoriasis.

243. The method of embodiment 242 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

244. The method of embodiment 243 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

245. The method of embodiment 243, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

246. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 280 mg per dose administered at time 0 (first administration), one week after time point 0, and then once a month after administration in the first week, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO : 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 receptor A.

247. The method of embodiment 246 wherein the psoriasis is plaque psoriasis.

248. The method of embodiment 247 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

249. The method of embodiment 248 wherein plaque psoriasis is moderate to

- 90 040869 severe is moderate to severe chronic plaque psoriasis and these patients are candidates for systemic therapy or phototherapy.

250. The method of embodiment 248, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

251. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of about 70 to about 300 mg of antibody per dose at time 0 (first administration ), one week after time point 0, and then once a month after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a variable domain sequence light chain containing SEQ ID NO: 4, and where the specified antibody specifically binds the receptor A of human IL-17.

252. The method of embodiment 251 wherein the psoriasis is plaque psoriasis.

253. The method of embodiment 252 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

254. The method of embodiment 253 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

255. The method of embodiment 253, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

256. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 70 mg per dose administered at time 0 (first administration), one week after time point 0, and then once a month after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 receptor A.

257. The method of embodiment 256 wherein the psoriasis is plaque psoriasis.

258. The method of embodiment 257 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

259. The method of embodiment 258 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

260. The method of embodiment 258, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

261. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg per dose administered at time 0 (first administration), one week after time point 0, and then once a month after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 receptor A.

262. The method of embodiment 261 wherein the psoriasis is plaque psoriasis.

263. The method of embodiment 262 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

264. The method of embodiment 263 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

- 91 040869

265. The method of embodiment 263, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

266. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 210 mg per dose administered at time 0 (first administration), one week after time point 0, and then once a month after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 receptor A.

267. The method of embodiment 266 wherein the psoriasis is plaque psoriasis.

268. The method of embodiment 267 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

269. The method of embodiment 268 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

270. The method of embodiment 268, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

271. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 280 mg per dose administered at time 0 (first administration), one week after time point 0, and then once a month after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 receptor A.

272. The method of embodiment 271 wherein the psoriasis is plaque psoriasis.

273. The method of embodiment 272 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

274. The method of embodiment 273 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

275. The method of embodiment 273, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

276. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of about 70 to about 300 mg of antibody per dose, conducted at time 0 (first administration ), one week after time point 0, and then once a month after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

277. The method of embodiment 276 wherein the psoriasis is plaque psoriasis.

278. The method of embodiment 277 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

279. The method of embodiment 278 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

280. The method of embodiment 278, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic methods

- 92 040869 therapies, including cyclosporine, methotrexate, and psoralen and ultraviolet-A phototherapy.

281. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 70 mg per dose administered at time 0 (first administration), one week after time point 0, and then once a month after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

282. The method of embodiment 281 wherein the psoriasis is plaque psoriasis.

283. The method of embodiment 282 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

284. The method of embodiment 283 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

285. The method of embodiment 283, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

286. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg per dose administered at time 0 (first administration), one week after time point 0, and then once a month after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

287. The method of embodiment 286 wherein the psoriasis is plaque psoriasis.

288. The method of embodiment 287 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

289. The method of embodiment 288 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

290. The method of embodiment 288, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

291. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 210 mg per dose administered at time 0 (first administration), one week after time point 0, and then once a month after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

292. The method of embodiment 291 wherein the psoriasis is plaque psoriasis.

293. The method of embodiment 292 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

294. The method of embodiment 293 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

295. The method of embodiment 293, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

296. A method for the treatment of psoriasis in adult and / or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 280 mg per dose, carried out at time point 0 (first administration -

- 93 040869 nie), one week after time point 0, and then once a month after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and the sequence light chain containing

SEQ ID NO: 2.

297. The method of embodiment 296 wherein the psoriasis is plaque psoriasis.

298. The method of embodiment 297 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

299. The method of embodiment 298 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

300. The method of embodiment 298, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

301. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg every two weeks when the weight of the patients is less than or approximately equal to 90 kg, and in a single or divided dose of 210 mg every two weeks in patients weighing more than 90 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO : 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 receptor A.

302. The method of embodiment 301 wherein the psoriasis is plaque psoriasis.

303. The method of embodiment 302 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

304. The method of embodiment 303 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

305. The method of embodiment 303, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

306. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg every two weeks when the weight of the patients is less than or approximately equal to 100 kg, and in a single or divided dose of 210 mg every two weeks in patients weighing more than 100 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO : 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 receptor A.

307. The method of embodiment 306 wherein the psoriasis is plaque psoriasis.

308. The method of embodiment 307 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

309. The method of embodiment 308 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

310. The method of embodiment 308, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

311. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg every two weeks when the weight of the patients is less than or approximately equal to 110 kg, and in single or divided dose of 210 mg every two weeks

- 94 040869 whether patients weighing more than 110 kg, where the specified antibody contains a heavy chain CDR1 containing

SEQ ID NO: 5, Heavy chain CDR2 containing SEQ ID NO: 7, Heavy chain CDR3 containing

SEQ ID NO: 8, Light chain CDR1 containing SEQ ID NO: 9, Light chain CDR2 containing

SEQ ID NO: 10, and a light chain CDR3 comprising SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

312. The method of embodiment 311 wherein the psoriasis is plaque psoriasis.

313. The method of embodiment 312 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

314. The method of embodiment 313 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

315. The method of embodiment 313, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

316. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg every two weeks when the weight of the patients is less than or approximately equal to 90 kg, and in a single or divided dose of 280 mg every two weeks in patients weighing more than 90 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO : 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 receptor A.

317. The method of embodiment 316 wherein the psoriasis is plaque psoriasis.

318. The method of embodiment 317 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

319. The method of embodiment 318 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

320. The method of embodiment 318, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

321. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg every two weeks, when the patient's weight is less than or approximately equal to 100 kg, and in a single or divided dose of 280 mg every two weeks in patients weighing more than 100 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO : 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 receptor A.

322. The method of embodiment 321 wherein the psoriasis is plaque psoriasis.

323. The method of embodiment 322 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

324. The method of embodiment 323 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

325. The method of embodiment 323, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

326. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg every two weeks, when the weight of the patients is

- 95 040869 less than or approximately equal to 110 kg, and in a single or divided dose of 280 mg every two weeks in patients weighing more than 110 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds human IL-17 receptor A.

327. The method of embodiment 326 wherein the psoriasis is plaque psoriasis.

328. The method of embodiment 327 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

329. The method of embodiment 328 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

330. The method of embodiment 328, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

331. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 280 mg every four weeks when the patient's weight is less than or approximately equal to 90 kg, and in a single or divided dose of 210 mg every two weeks in patients weighing more than 90 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO : 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 receptor A.

332. The method of embodiment 331 wherein the psoriasis is plaque psoriasis.

333. The method of embodiment 332 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

334. The method of embodiment 333 wherein the moderate to severe plaque psoriasis is moderate to severe chronic plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

335. The method of embodiment 333, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

336. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 280 mg every four weeks when the weight of the patients is less than or approximately equal to 100 kg, and in a single or divided dose of 210 mg every two weeks in patients weighing more than 100 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO : 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 receptor A.

337. The method of embodiment 336 wherein the psoriasis is plaque psoriasis.

338. The method of embodiment 337 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

339. The method of embodiment 338 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

340. The method of embodiment 338, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

341. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing an isolated anti

- 96 040869 body in a single or divided dose of 280 mg every four weeks, when the weight of patients is less than or approximately equal to 110 kg, and in a single or divided dose of 210 mg every two weeks in patients weighing more than 110 kg, where the specified antibody contains CDR1 severe chain containing SEQ ID NO: 5, heavy chain CDR2 containing SEQ ID NO: 7, heavy chain CDR3 containing SEQ ID NO: 8, light chain CDR1 containing SEQ ID NO: 9, light chain CDR2 containing SEQ ID NO : 10, and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

342. The method of embodiment 341 wherein the psoriasis is plaque psoriasis.

343. The method of embodiment 342 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

344. The method of embodiment 343 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

345. The method of embodiment 343, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

346. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 280 mg every four weeks when the weight of the patients is less than or approximately equal to 90 kg, and in a single or divided dose of 280 mg every two weeks in patients weighing more than 90 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO : 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 receptor A.

347. The method of embodiment 346 wherein the psoriasis is plaque psoriasis.

348. The method of embodiment 347 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

349. The method of embodiment 348 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

350. The method of embodiment 348, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

351. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing an isolated antibody in a single or divided dose of 280 mg every four weeks when the patient's weight is less than or approximately equal to 100 kg, and in a single or divided dose of 280 mg every two weeks in patients weighing more than 100 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO : 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 receptor A.

352. The method of embodiment 351 wherein the psoriasis is plaque psoriasis.

353. The method of embodiment 352 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

354. The method of embodiment 353 wherein the moderate to severe plaque psoriasis is moderate to severe chronic plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

355. The method of embodiment 323, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

356. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, including

- 97 040869 teasing the introduction to the specified patient of a pharmaceutical composition containing the isolated antibody in a single or divided dose of 280 mg every four weeks, when the weight of patients is less than or approximately equal to 110 kg, and in a single or divided dose of 280 mg every two weeks in patients weighing more than 110 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9 , a light chain CDR2 comprising SEQ ID NO: 10 and a light chain CDR3 comprising SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

357. The method of embodiment 356 wherein the psoriasis is plaque psoriasis.

358. The method of embodiment 357 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

359. The method of embodiment 358 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

360. The method of embodiment 358, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

361. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg every two weeks when the weight of the patients is less than or approximately equal to 90 kg, and in a single or divided dose of 210 mg every two weeks in patients weighing more than 90 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 receptor A.

362. The method of embodiment 361 wherein the psoriasis is plaque psoriasis.

363. The method of embodiment 362 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

364. The method of embodiment 363 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

365. The method of embodiment 363, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

366. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg every two weeks when the weight of the patients is less than or approximately equal to 100 kg, and in a single or divided dose of 210 mg every two weeks in patients weighing more than 100 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 receptor A.

367. The method of embodiment 366 wherein the psoriasis is plaque psoriasis.

368. The method of embodiment 367 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

369. The method of embodiment 368 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

370. The method of embodiment 368, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

371. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing isolated anti

- 98 040869 body in a single or divided dose of 140 mg every two weeks when the weight of patients is less than or approximately equal to 110 kg, and in a single or divided dose of 210 mg every two weeks in patients weighing more than 110 kg, where the specified antibody or its binding The IL-17RA fragment contains a heavy chain variable domain sequence comprising SEQ ID NO: 3 and a light chain variable domain sequence comprising SEQ ID NO: 4, and wherein said antibody specifically binds the human IL-17 receptor A.

372. The method of embodiment 371 wherein the psoriasis is plaque psoriasis.

373. The method of embodiment 372 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

374. The method of embodiment 373 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

375. The method of embodiment 373, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

376. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg every two weeks, when the weight of the patients is less than or approximately equal to 90 kg, and in a single or divided dose of 280 mg every two weeks in patients weighing more than 90 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 receptor A.

377. The method of embodiment 376 wherein the psoriasis is plaque psoriasis.

378. The method of embodiment 377 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

379. The method of embodiment 378 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

380. The method of embodiment 378, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

381. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg every two weeks when the patient's weight is less than or approximately equal to 100 kg, and in a single or divided dose of 280 mg every two weeks in patients weighing more than 100 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 receptor A.

382. The method of embodiment 381 wherein the psoriasis is plaque psoriasis.

383. The method of embodiment 382 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

384. The method of embodiment 383 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

385. The method of embodiment 383, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

386. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg every two weeks when the patient's weight is less than or approximately equal to 110 kg, and in single or divided dose of 280 mg every two weeks

- 99 040869 whether patients weighing more than 110 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 receptor A.

387. The method of embodiment 386 wherein the psoriasis is plaque psoriasis.

388. The method of embodiment 387 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

389. The method of embodiment 388 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

390. The method of embodiment 388, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

391. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 280 mg every four weeks when the weight of the patients is less than or approximately equal to 90 kg, and in a single or divided dose of 210 mg every two weeks in patients weighing more than 90 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 receptor A.

392. The method of embodiment 391 wherein the psoriasis is plaque psoriasis.

393. The method of embodiment 392 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

394. The method of embodiment 393 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

395. The method of embodiment 393, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

396. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing an isolated antibody in a single or divided dose of 280 mg every four weeks when the patient's weight is less than or approximately equal to 100 kg, and in a single or divided dose of 210 mg every two weeks in patients weighing more than 100 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 receptor A.

397. The method of embodiment 396 wherein the psoriasis is plaque psoriasis.

398. The method of embodiment 397 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

399. The method of embodiment 398 wherein the moderate to severe plaque psoriasis is moderate to severe chronic plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

400. The method of embodiment 398, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

401. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 280 mg every four weeks when the weight of the patients is less than or approximately equal to 110 kg, and in a single or divided dose of 210 mg every two weeks in patients weighing more than 110 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and then -

- 100 040869 a light chain variable domain value comprising SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 A receptor.

402. The method of embodiment 401 wherein the psoriasis is plaque psoriasis.

403. The method of embodiment 402 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

404. The method of embodiment 403 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

405. The method of embodiment 403, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

406. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 280 mg every four weeks when the weight of the patients is less than or approximately equal to 90 kg, and in a single or divided dose of 280 mg every two weeks in patients weighing more than 90 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 receptor A.

407. The method of embodiment 406 wherein the psoriasis is plaque psoriasis.

408. The method of embodiment 407 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

409. The method of embodiment 408 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

410. The method of embodiment 408, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

411. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 280 mg every four weeks when the weight of the patients is less than or approximately equal to 100 kg, and in a single or divided dose of 280 mg every two weeks in patients weighing more than 100 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 receptor A.

412. The method of embodiment 411 wherein the psoriasis is plaque psoriasis.

413. The method of embodiment 412 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

414. The method of embodiment 413 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

415. The method of embodiment 413, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

416. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 280 mg every four weeks when the weight of the patients is less than or approximately equal to 110 kg, and in a single or divided dose of 280 mg every two weeks in patients weighing more than 110 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 receptor A.

- 101 040869

417. The method of embodiment 416 wherein the psoriasis is plaque psoriasis.

418. The method of embodiment 417 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

419. The method of embodiment 418 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

420. The method of embodiment 418, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

421. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg every two weeks when the weight of the patients is less than or approximately equal to 90 kg, and in a single or divided dose of 210 mg every two weeks to patients weighing more than 90 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

422. The method of embodiment 421 wherein the psoriasis is plaque psoriasis.

423. The method of embodiment 422 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

424. The method of embodiment 423 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

425. The method of embodiment 423, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

426. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg every two weeks when the weight of the patients is less than or approximately equal to 100 kg, and in a single or divided dose of 210 mg every two weeks to patients weighing more than 100 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

427. The method of embodiment 426 wherein the psoriasis is plaque psoriasis.

428. The method of embodiment 427 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

429. The method of embodiment 428 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

430. The method of embodiment 428, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

431. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg every two weeks when the weight of the patients is less than or approximately equal to 110 kg, and in a single or divided dose of 210 mg every two weeks to patients weighing more than 110 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

432. The method of embodiment 431 wherein the psoriasis is plaque psoriasis.

433. The method of embodiment 432 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

434. The method of embodiment 433 wherein plaque psoriasis is moderate to

- 102 040869 severe is moderate to severe chronic plaque psoriasis and these patients are candidates for systemic therapy or phototherapy.

435. The method of embodiment 433, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

436. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg every two weeks when the weight of the patients is less than or approximately equal to 90 kg, and in a single or divided dose of 280 mg every two weeks to patients weighing more than 90 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

437. The method of embodiment 436 wherein the psoriasis is plaque psoriasis.

438. The method of embodiment 437 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

439. The method of embodiment 438 wherein the moderate to severe plaque psoriasis is moderate to severe chronic plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

440. The method of embodiment 438, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

441. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg every two weeks when the weight of the patients is less than or approximately equal to 100 kg, and in a single or divided dose of 280 mg every two weeks to patients weighing more than 100 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

442. The method of embodiment 441 wherein the psoriasis is plaque psoriasis.

443. The method of embodiment 442 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

444. The method of embodiment 443 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

445. The method of embodiment 443, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

446. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 140 mg every two weeks when the weight of the patients is less than or approximately equal to 110 kg, and in a single or divided dose of 280 mg every two weeks to patients weighing more than 110 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

447. The method of embodiment 446 wherein the psoriasis is plaque psoriasis.

448. The method of embodiment 447 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

449. The method of embodiment 448 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

450. The method of embodiment 448, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients do not respond, contraindicate, or cannot tolerate other systemic methods

- 103 040869 therapies, including cyclosporine, methotrexate, and psoralen and ultraviolet-A phototherapy.

451. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 280 mg every four weeks when the weight of the patients is less than or approximately equal to 90 kg, and in a single or divided dose of 210 mg every two weeks to patients weighing more than 90 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

452. The method of embodiment 451 wherein the psoriasis is plaque psoriasis.

453. The method of embodiment 452 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

454. The method of embodiment 453 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

455. The method of embodiment 453, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

456. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 280 mg every four weeks when the weight of the patients is less than or approximately equal to 100 kg, and in a single or divided dose of 210 mg every two weeks to patients weighing more than 100 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

457. The method of embodiment 456 wherein the psoriasis is plaque psoriasis.

458. The method of embodiment 457 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

459. The method of embodiment 458 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

460. The method of embodiment 458, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

461. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 280 mg every four weeks when the weight of the patients is less than or approximately equal to 110 kg, and in a single or divided dose of 210 mg every two weeks to patients weighing more than 110 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

462. The method of embodiment 461 wherein the psoriasis is plaque psoriasis.

463. The method of embodiment 462 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

464. The method of embodiment 463 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

465. The method of embodiment 463, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

466. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 280 mg every four weeks, when the weight of the patients is

- 104 040869 less than or approximately equal to 90 kg, and in a single or divided dose of 280 mg every two weeks in patients weighing more than 90 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

467. The method of embodiment 466 wherein the psoriasis is plaque psoriasis.

468. The method of embodiment 467 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

469. The method of embodiment 468 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

470. The method of embodiment 468, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

471. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 280 mg every four weeks when the weight of the patients is less than or approximately equal to 100 kg, and in a single or divided dose of 280 mg every two weeks to patients weighing more than 100 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

472. The method of embodiment 471 wherein the psoriasis is plaque psoriasis.

473. The method of embodiment 472 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

474. The method of embodiment 473 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

475. The method of embodiment 473, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

476. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing the isolated antibody in a single or divided dose of 280 mg every four weeks when the weight of the patients is less than or approximately equal to 110 kg, and in a single or divided dose of 280 mg every two weeks to patients weighing more than 110 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

477. The method of embodiment 476 wherein the psoriasis is plaque psoriasis.

478. The method of embodiment 477 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

479. The method of embodiment 478 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

480. The method of embodiment 478, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

481. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/mL antibody in a single or divided dose of about 70 to about 300 mg antibody per dose given at time 0 (first administration), one week after time 0 , and then carried out every two weeks after administration in the first week, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, Light chain CDR1 comprising SEQ ID NO: 9, CDR2

- 105 040869 light chain containing SEQ ID NO: 10, and light chain CDR3 containing SEQ ID NO: 11, and where the specified antibody specifically binds the human IL-17 receptor A.

482. The method of embodiment 481 wherein the psoriasis is plaque psoriasis.

483. The method of embodiment 482 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

484. The method of embodiment 483 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

485. The method of embodiment 483, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

486. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/mL antibody in a single or divided dose of 70 mg per dose administered at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10 and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

487. The method of embodiment 486 wherein the psoriasis is plaque psoriasis.

488. The method of embodiment 487 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

489. The method of embodiment 488 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

490. The method of embodiment 488, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and psoralen and ultraviolet phototherapy radiation-A.

491. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/mL antibody in a single or divided dose of 140 mg per dose administered at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10 and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

492. The method of embodiment 491 wherein the psoriasis is plaque psoriasis.

493. The method of embodiment 492 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

494. The method of embodiment 493 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

495. The method of embodiment 493, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

496. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/ml antibody in

- 106 040869 a single or divided dose of 210 mg per dose administered at time 0 (first administration), one week after time 0, and then administered every two weeks after administration in the first week, where said antibody contains a heavy chain CDR1, containing SEQ ID NO: 5, heavy chain CDR2 containing SEQ ID NO: 7, heavy chain CDR3 containing SEQ ID NO: 8, light chain CDR1 containing SEQ ID NO: 9, light chain CDR2 containing SEQ ID NO: 10 , and a light chain CDR3 comprising SEQ ID NO: 11, and wherein said antibody specifically binds human IL-17 receptor A.

497. The method of embodiment 496 wherein the psoriasis is plaque psoriasis.

498. The method of embodiment 497 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

499. The method of embodiment 498 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

500. The method of embodiment 498, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

501. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 280 mg per dose administered at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10 and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

502. The method of embodiment 501 wherein the psoriasis is plaque psoriasis.

503. The method of embodiment 502 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

504. The method of embodiment 503 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

505. The method of embodiment 503, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

506. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/mL antibody in a single or divided dose of about 70 to about 300 mg antibody per dose given at time 0 (first administration), one week after time 0 , and then carried out every two weeks after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4 , and wherein said antibody specifically binds human IL-17 receptor A.

507. The method of embodiment 506 wherein the psoriasis is plaque psoriasis.

508. The method of embodiment 507 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

509. The method of embodiment 508 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

510. The method of embodiment 508, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet

- 107 040869 radiation-A.

511. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/mL antibody in a single or divided dose of 70 mg per dose administered at time 0 (first administration), one week after time 0, and then every two weeks after administration the first week, wherein said antibody or IL-17RA binding fragment thereof comprises a heavy chain variable domain sequence comprising SEQ ID NO: 3 and a light chain variable domain sequence comprising SEQ ID NO: 4, and wherein said antibody is specific binds the human IL-17 A receptor.

512. The method of embodiment 511 wherein the psoriasis is plaque psoriasis.

513. The method of embodiment 512 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

514. The method of embodiment 513 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

515. The method of embodiment 513, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

516. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/mL antibody in a single or divided dose of 140 mg per dose administered at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week, wherein said antibody or IL-17RA binding fragment thereof comprises a heavy chain variable domain sequence comprising SEQ ID NO: 3 and a light chain variable domain sequence comprising SEQ ID NO: 4, and wherein said antibody is specific binds the human IL-17 A receptor.

517. The method of embodiment 516 wherein the psoriasis is plaque psoriasis.

518. The method of embodiment 517 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

519. The method of embodiment 518 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

520. The method of embodiment 518, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

521. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 210 mg per dose administered at time 0 (first administration), one week after time 0, and then every two weeks after administration the first week, wherein said antibody or IL-17RA binding fragment thereof comprises a heavy chain variable domain sequence comprising SEQ ID NO: 3 and a light chain variable domain sequence comprising SEQ ID NO: 4, and wherein said antibody is specific binds the human IL-17 A receptor.

522. The method of embodiment 521 wherein the psoriasis is plaque psoriasis.

523. The method of embodiment 522 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

524. The method of embodiment 523 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

525. The method of embodiment 523 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and wherein:

- 108 040869 These patients do not respond, have a contraindication, or do not tolerate other systemic therapies, including cyclosporine, methotrexate, and psoralen and ultraviolet-A phototherapy.

526. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 280 mg per dose administered at time 0 (first administration), one week after time 0, and then every two weeks after administration the first week, wherein said antibody or IL-17RA binding fragment thereof comprises a heavy chain variable domain sequence comprising SEQ ID NO: 3 and a light chain variable domain sequence comprising SEQ ID NO: 4, and wherein said antibody is specific binds the human IL-17 A receptor.

527. The method of embodiment 526 wherein the psoriasis is plaque psoriasis.

528. The method of embodiment 527 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

529. The method of embodiment 528 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

530. The method of embodiment 528, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

531. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/mL antibody in a single or divided dose of about 70 to about 300 mg antibody per dose given at time 0 (first administration), one week after time 0 , and then carried out every two weeks after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

532. The method of embodiment 531 wherein the psoriasis is plaque psoriasis.

533. The method of embodiment 532 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

534. The method of embodiment 533 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

535. The method of embodiment 533, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

536. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/mL antibody in a single or divided dose of 70 mg per dose administered at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week, wherein said antibody or IL-17RA binding fragment thereof contains a heavy chain sequence comprising SEQ ID NO: 1 and a light chain sequence comprising SEQ ID NO: 2.

537. The method of embodiment 536 wherein the psoriasis is plaque psoriasis.

538. The method of embodiment 537 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

539. The method of embodiment 538 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

540. The method of embodiment 538, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein:

- 109 040869 These patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and psoralen and ultraviolet-A phototherapy.

541. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/mL antibody in a single or divided dose of 140 mg per dose administered at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week, wherein said antibody or IL-17RA binding fragment thereof contains a heavy chain sequence comprising SEQ ID NO: 1 and a light chain sequence comprising SEQ ID NO: 2.

542. The method of embodiment 541 wherein the psoriasis is plaque psoriasis.

543. The method of embodiment 542 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

544. The method of embodiment 543 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

545. The method of embodiment 543, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

546. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 210 mg per dose administered at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week, wherein said antibody or IL-17RA binding fragment thereof contains a heavy chain sequence comprising SEQ ID NO: 1 and a light chain sequence comprising SEQ ID NO: 2.

547. The method of embodiment 546 wherein the psoriasis is plaque psoriasis.

548. The method of embodiment 547 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

549. The method of embodiment 548 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

550. The method of embodiment 548, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

551. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 280 mg per dose administered at time 0 (first administration), one week after time 0, and then every two weeks after administration in the first week, wherein said antibody or IL-17RA binding fragment thereof contains a heavy chain sequence comprising SEQ ID NO: 1 and a light chain sequence comprising SEQ ID NO: 2.

552. The method of embodiment 551 wherein the psoriasis is plaque psoriasis.

553. The method of embodiment 552 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

554. The method of embodiment 553 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

555. The method of embodiment 553, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients do not respond, contraindicate, or cannot tolerate other systemic methods

- 110 040869 therapies, including cyclosporine, methotrexate, and psoralen and ultraviolet-A phototherapy.

556. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/mL antibody in a single or divided dose of about 70 to about 300 mg antibody per dose given at time 0 (first administration), one week after time 0 , and then once a month after administration in the first week, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, A light chain CDR1 comprising SEQ ID NO: 9, a light chain CDR2 comprising SEQ ID NO: 10, and a light chain CDR3 comprising SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

557. The method of embodiment 556 wherein the psoriasis is plaque psoriasis.

558. The method of embodiment 557 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

559. The method of embodiment 558 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

560. The method of embodiment 558, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

561. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/mL antibody in a single or divided dose of 70 mg per dose given at time 0 (first administration), one week after time 0, and then every other month after administration in the first week, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10 and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

562. The method of embodiment 561 wherein the psoriasis is plaque psoriasis.

563. The method of embodiment 562 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

564. The method of embodiment 563 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

565. The method of embodiment 563, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

566. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/mL antibody in a single or divided dose of 140 mg per dose given at time 0 (first administration), one week after time 0, and then every other month after administration in the first week, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10 and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

567. The method of embodiment 566 wherein the psoriasis is plaque psoriasis.

568. The method of embodiment 567 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

569. The method of embodiment 568 wherein plaque psoriasis is moderate to

- 111 040869 severe is moderate to severe chronic plaque psoriasis and these patients are candidates for systemic therapy or phototherapy.

570. The method of embodiment 568, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

571. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/mL antibody in a single or divided dose of 210 mg per dose given at time 0 (first administration), one week after time 0, and then every other month after administration in the first week, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10 and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

572. The method of embodiment 571 wherein the psoriasis is plaque psoriasis.

573. The method of embodiment 572 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

574. The method of embodiment 573 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

575. The method of embodiment 573, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

576. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/mL antibody in a single or divided dose of 280 mg per dose given at time 0 (first administration), one week after time 0, and then every other month after administration in the first week, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10 and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

577. The method of embodiment 576 wherein the psoriasis is plaque psoriasis.

578. The method of embodiment 577 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

579. The method of embodiment 578 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

580. The method of embodiment 578, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

581. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/mL antibody in a single or divided dose of about 70 to about 300 mg antibody per dose given at time 0 (first administration), one week after time 0 , and then once a month after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4 , and wherein said antibody specifically binds human IL-17 receptor A.

582. The method of embodiment 581 wherein the psoriasis is plaque

- 112 040869 psoriasis.

583. The method of embodiment 582 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

584. The method of embodiment 583 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

585. The method of embodiment 583, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

586. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/mL antibody in a single or divided dose of 70 mg per dose given at time 0 (first administration), one week after time 0, and then every other month after administration in the first week, wherein said antibody or IL-17RA binding fragment thereof contains a heavy chain variable domain sequence comprising SEQ ID NO: 3 and a light chain variable domain sequence comprising SEQ ID NO: 4, and wherein said antibody is specific binds the human IL-17 A receptor.

587. The method of embodiment 586 wherein the psoriasis is plaque psoriasis.

588. The method of embodiment 587 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

589. The method of embodiment 588 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

590. The method of embodiment 588, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

591. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/mL antibody in a single or divided dose of 140 mg per dose given at time 0 (first administration), one week after time 0, and then every other month after administration in the first week, wherein said antibody or IL-17RA binding fragment thereof contains a heavy chain variable domain sequence comprising SEQ ID NO: 3 and a light chain variable domain sequence comprising SEQ ID NO: 4, and wherein said antibody is specific binds the human IL-17 A receptor.

592. The method of embodiment 591 wherein the psoriasis is plaque psoriasis.

593. The method of embodiment 592 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

594. The method of embodiment 593 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

595. The method of embodiment 593, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

596. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/mL antibody in a single or divided dose of 210 mg per dose given at time 0 (first administration), one week after time 0, and then every other month after administration in the first week, wherein said antibody or IL-17RA binding fragment thereof contains a heavy chain variable domain sequence comprising SEQ ID NO: 3 and a light chain variable domain sequence comprising SEQ ID NO: 4, and wherein said antibody is specific binds the recipe

- 113 040869 tor A human IL-17.

597. The method of embodiment 596 wherein the psoriasis is plaque psoriasis.

598. The method of embodiment 597 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

599. The method of embodiment 598 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

600. The method of embodiment 598, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

601. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/mL antibody in a single or divided dose of 280 mg per dose given at time 0 (first administration), one week after time 0, and then every other month after administration in the first week, wherein said antibody or IL-17RA binding fragment thereof contains a heavy chain variable domain sequence comprising SEQ ID NO: 3 and a light chain variable domain sequence comprising SEQ ID NO: 4, and wherein said antibody is specific binds the human IL-17 A receptor.

602. The method of embodiment 601 wherein the psoriasis is plaque psoriasis.

603. The method of embodiment 602 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

604. The method of embodiment 603 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

605. The method of embodiment 603, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

606. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/mL antibody in a single or divided dose of about 70 to about 300 mg antibody per dose given at time 0 (first administration), one week after time 0 , and then once a month after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

607. The method of embodiment 606 wherein the psoriasis is plaque psoriasis.

608. The method of embodiment 607 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

609. The method of embodiment 608 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

610. The method of embodiment 608, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

611. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/mL antibody in a single or divided dose of 70 mg per dose given at time 0 (first administration), one week after time 0, and then every other month after administration in the first week, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing

- 114 040869

SEQ ID NO: 2.

612. The method of embodiment 611 wherein the psoriasis is plaque psoriasis.

613. The method of embodiment 612 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

614. The method of embodiment 613 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

615. The method of embodiment 613, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

616. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/mL antibody in a single or divided dose of 140 mg per dose given at time 0 (first administration), one week after time 0, and then every other one month after administration in the first week, where said antibody or IL-17RA binding fragment thereof contains a heavy chain sequence containing SEQ ID NO: 1 and a light chain sequence containing SEQ ID NO: 2.

617. The method of embodiment 616 wherein the psoriasis is plaque psoriasis.

618. The method of embodiment 617 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

619. The method of embodiment 618 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

620. The method of embodiment 618, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

621. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/mL antibody in a single or divided dose of 210 mg per dose given at time 0 (first administration), one week after time 0, and then every other one month after administration in the first week, where said antibody or IL-17RA binding fragment thereof contains a heavy chain sequence containing SEQ ID NO: 1 and a light chain sequence containing SEQ ID NO: 2.

622. The method of embodiment 621 wherein the psoriasis is plaque psoriasis.

623. The method of embodiment 622 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

624. The method of embodiment 623 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

625. The method of embodiment 623, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

626. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/mL antibody in a single or divided dose of 280 mg per dose given at time 0 (first administration), one week after time 0, and then every other one month after administration in the first week, where said antibody or IL-17RA binding fragment thereof contains a heavy chain sequence containing SEQ ID NO: 1 and a light chain sequence containing SEQ ID NO: 2.

- 115 040869

627. The method of embodiment 626 wherein the psoriasis is plaque psoriasis.

628. The method of embodiment 627 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

629. The method of embodiment 628 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

630. The method of embodiment 628, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

631. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 140 mg every two weeks when patients weigh less than or approximately equal to 90 kg, and in a single or divided dose of 210 mg every two weeks patients weighing more than 90 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10 and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

632. The method of embodiment 631 wherein the psoriasis is plaque psoriasis.

633. The method of embodiment 632 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

634. The method of embodiment 633 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

635. The method of embodiment 633, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

636. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 140 mg every two weeks when patients weigh less than or approximately equal to 100 kg, and in a single or divided dose of 210 mg every two weeks patients weighing more than 100 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10 and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

637. The method of embodiment 636 wherein the psoriasis is plaque psoriasis.

638. The method of embodiment 637 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

639. The method of embodiment 638 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

640. The method of embodiment 638, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

641. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 140 mg every two weeks when patients weigh less than or approximately equal to 110 kg, and in a single or divided dose of 210 mg every two weeks patients

- 116 040869 weighing more than 110 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5,

A heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8,

A light chain CDR1 comprising SEQ ID NO: 9, a light chain CDR2 comprising SEQ ID NO: 10, and

A light chain CDR3 comprising SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

642. The method of embodiment 641 wherein the psoriasis is plaque psoriasis.

643. The method of embodiment 642 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

644. The method of embodiment 643 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

645. The method of embodiment 643, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

646. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 140 mg every two weeks when patients weigh less than or approximately equal to 90 kg, and in a single or divided dose of 280 mg every two weeks patients weighing more than 90 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10 and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

647. The method of embodiment 646 wherein the psoriasis is plaque psoriasis.

648. The method of embodiment 647 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

649. The method of embodiment 648 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

650. The method of embodiment 648, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

651. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 140 mg every two weeks when patients weigh less than or approximately equal to 100 kg, and in a single or divided dose of 280 mg every two weeks patients weighing more than 100 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10 and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

652. The method of embodiment 651 wherein the psoriasis is plaque psoriasis.

653. The method of embodiment 652 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

654. The method of embodiment 653 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

655. The method of embodiment 653, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

- 117 040869

656. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 140 mg every two weeks when patients weigh less than or approximately equal to 110 kg, and in a single or divided dose of 280 mg every two weeks patients weighing more than 110 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10 and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

657. The method of embodiment 656 wherein the psoriasis is plaque psoriasis.

658. The method of embodiment 657 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

659. The method of embodiment 658 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

660. The method of embodiment 658, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

661. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 280 mg every four weeks when patients weigh less than or approximately equal to 90 kg, and in a single or divided dose of 210 mg every two weeks patients weighing more than 90 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10 and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

662. The method of embodiment 661 wherein the psoriasis is plaque psoriasis.

663. The method of embodiment 662 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

664. The method of embodiment 663 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

665. The method of embodiment 663, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

666. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 280 mg every four weeks when patients weigh less than or approximately equal to 100 kg, and in a single or divided dose of 210 mg every two weeks patients weighing more than 100 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10 and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

667. The method of embodiment 666 wherein the psoriasis is plaque psoriasis.

668. The method of embodiment 667 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

669. The method of embodiment 668 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

- 118 040869

670. The method of embodiment 668, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

671. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 280 mg every four weeks when patients weigh less than or approximately equal to 110 kg, and in a single or divided dose of 210 mg every two weeks patients weighing more than 110 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10 and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

672. The method of embodiment 671 wherein the psoriasis is plaque psoriasis.

673. The method of embodiment 672 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

674. The method of embodiment 673 wherein the moderate to severe plaque psoriasis is moderate to severe chronic plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

675. The method of embodiment 673, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

676. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 280 mg every four weeks when patients weigh less than or approximately equal to 90 kg, and in a single or divided dose of 280 mg every two weeks patients weighing more than 90 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10 and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

677. The method of embodiment 676 wherein the psoriasis is plaque psoriasis.

678. The method of embodiment 677 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

679. The method of embodiment 678 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

680. The method of embodiment 678, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

681. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 280 mg every four weeks when patients weigh less than or approximately equal to 100 kg, and in a single or divided dose of 280 mg every two weeks patients weighing more than 100 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10 and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

682. The method of embodiment 681 wherein the psoriasis is plaque psoriasis.

- 119 040869

683. The method of embodiment 682 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

684. The method of embodiment 683 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

685. The method of embodiment 683, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

686. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 280 mg every four weeks when patients weigh less than or approximately equal to 110 kg, and in a single or divided dose of 280 mg every two weeks patients weighing more than 110 kg, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10 and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds the human IL-17 A receptor.

687. The method of embodiment 686 wherein the psoriasis is plaque psoriasis.

688. The method of embodiment 687 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

689. The method of embodiment 688 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

690. The method of embodiment 688, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

691. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 140 mg every two weeks when patients weigh less than or approximately equal to 90 kg, and in a single or divided dose of 210 mg every two weeks patients weighing more than 90 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and where the specified antibody is specific binds the human IL-17 A receptor.

692. The method of embodiment 691 wherein the psoriasis is plaque psoriasis.

693. The method of embodiment 692 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

694. The method of embodiment 693 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

695. The method of embodiment 693, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

696. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 140 mg every two weeks when patients weigh less than or approximately equal to 100 kg, and in a single or divided dose of 210 mg every two weeks patients weighing more than 100 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and where the specified antibody is specific

- 120 040869 binds human IL-17 receptor A.

697. The method of embodiment 696 wherein the psoriasis is plaque psoriasis.

698. The method of embodiment 697 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

699. The method of embodiment 698 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

700. The method of embodiment 698, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

701. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 140 mg every two weeks when patients weigh less than or approximately equal to 110 kg, and in a single or divided dose of 210 mg every two weeks patients weighing more than 110 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and where the specified antibody is specific binds the human IL-17 A receptor.

702. The method of embodiment 701 wherein the psoriasis is plaque psoriasis.

703. The method of embodiment 702 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

704. The method of embodiment 703 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

705. The method of embodiment 703, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

706. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 140 mg every two weeks when patients weigh less than or approximately equal to 90 kg, and in a single or divided dose of 280 mg every two weeks patients weighing more than 90 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and where the specified antibody is specific binds the human IL-17 A receptor.

707. The method of embodiment 706 wherein the psoriasis is plaque psoriasis.

708. The method of embodiment 707 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

709. The method of embodiment 708 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

710. The method of embodiment 708, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

711. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 140 mg every two weeks when patients weigh less than or approximately equal to 100 kg, and in a single or divided dose of 280 mg every two weeks patients weighing more than 100 kg, where the specified antibody or its IL-17RA binding fragment contains a post-

- 121 040869 a heavy chain variable domain sequence comprising SEQ ID NO: 3 and a light chain variable domain sequence comprising SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 receptor A.

712. The method of embodiment 711 wherein the psoriasis is plaque psoriasis.

713. The method of embodiment 712 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

714. The method of embodiment 713 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

715. The method of embodiment 713, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

716. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 140 mg every two weeks when patients weigh less than or approximately equal to 110 kg, and in a single or divided dose of 280 mg every two weeks patients weighing more than 110 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and where the specified antibody is specific binds the human IL-17 A receptor.

717. The method of embodiment 716 wherein the psoriasis is plaque psoriasis.

718. The method of embodiment 717 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

719. The method of embodiment 718 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

720. The method of embodiment 718, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

721. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 280 mg every four weeks when patients weigh less than or approximately equal to 90 kg, and in a single or divided dose of 210 mg every two weeks patients weighing more than 90 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and where the specified antibody is specific binds the human IL-17 A receptor.

722. The method of embodiment 721 wherein the psoriasis is plaque psoriasis.

723. The method of embodiment 722 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

724. The method of embodiment 723 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

725. The method of embodiment 723, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

726. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/mL antibody in a single or divided dose of 280 mg every four weeks when patients are underweight

- 122 040869 or approximately equal to 100 kg, and in a single or divided dose of 210 mg every two weeks in patients weighing more than 100 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3 , and a light chain variable domain sequence comprising SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 A receptor.

727. The method of embodiment 726 wherein the psoriasis is plaque psoriasis.

728. The method of embodiment 727 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

729. The method of embodiment 728 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

730. The method of embodiment 728, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

731. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 280 mg every four weeks when patients weigh less than or approximately equal to 110 kg, and in a single or divided dose of 210 mg every two weeks patients weighing more than 110 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and where the specified antibody is specific binds the human IL-17 A receptor.

732. The method of embodiment 731 wherein the psoriasis is plaque psoriasis.

733. The method of embodiment 732 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

734. The method of embodiment 733 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

735. The method of embodiment 733, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

736. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 280 mg every four weeks when patients weigh less than or approximately equal to 90 kg, and in a single or divided dose of 280 mg every two weeks patients weighing more than 90 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and where the specified antibody is specific binds the human IL-17 A receptor.

737. The method of embodiment 736 wherein the psoriasis is plaque psoriasis.

738. The method of embodiment 737 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

739. The method of embodiment 738 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

740. The method of embodiment 738, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

741. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamine-

- 123 040869 acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/ml antibody in single or divided dose 280 mg every four weeks when patients weigh less than or approximately equal to 100 kg, and in a single or divided dose of 280 mg every two weeks in patients weighing more than 100 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3 and a light chain variable domain sequence containing SEQ ID NO: 4, and wherein said antibody specifically binds the human IL-17 A receptor.

742. The method of embodiment 741 wherein the psoriasis is plaque psoriasis.

743. The method of embodiment 742 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

744. The method of embodiment 743 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

745. The method of embodiment 743, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

746. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 280 mg every four weeks when patients weigh less than or approximately equal to 110 kg, and in a single or divided dose of 280 mg every two weeks patients weighing more than 110 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and where the specified antibody is specific binds the human IL-17 A receptor.

747. The method of embodiment 746 wherein the psoriasis is plaque psoriasis.

748. The method of embodiment 747 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

749. The method of embodiment 748 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

750. The method of embodiment 748, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

751. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 140 mg every two weeks when patients weigh less than or approximately equal to 90 kg, and in a single or divided dose of 210 mg every two weeks patients weighing more than 90 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

752. The method of embodiment 751 wherein the psoriasis is plaque psoriasis.

753. The method of embodiment 752 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

754. The method of embodiment 753 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

755. The method of embodiment 753, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

756. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, including

- 124 040869 teasing the introduction to the specified patient of a pharmaceutical composition containing 10 mm glutamic acid, 3 wt./vol.% L-proline, 0.01 wt./vol.% polysorbate 20, pH 4.8±0.2, and 140 mg/ml antibody at a single or divided dose of 140 mg every two weeks when patients weigh less than or approximately equal to 100 kg, and at a single or divided dose of 210 mg every two weeks in patients weighing more than 100 kg, where the specified antibody or its binding The IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1 and a light chain sequence containing SEQ ID NO: 2.

757. The method of embodiment 756 wherein the psoriasis is plaque psoriasis.

758. The method of embodiment 757 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

759. The method of embodiment 758 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

760. The method of embodiment 758, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

761. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 140 mg every two weeks when patients weigh less than or approximately equal to 110 kg, and in a single or divided dose of 210 mg every two weeks patients weighing more than 110 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

762. The method of embodiment 761 wherein the psoriasis is plaque psoriasis.

763. The method of embodiment 762 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

764. The method of embodiment 763 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

765. The method of embodiment 763, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

766. A method of treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 140 mg every two weeks when patients weigh less than or approximately equal to 90 kg, and in a single or divided dose of 280 mg every two weeks patients weighing more than 90 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

767. The method of embodiment 766 wherein the psoriasis is plaque psoriasis.

768. The method of embodiment 767 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

769. The method of embodiment 768 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

770. The method of embodiment 768, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

771. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, which includes administering to said patient a pharmaceutical composition containing 10 mM glutamino

- 125 040869 acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140mg/ml antibody in single or divided dose 140 mg every two weeks when patients weigh less than or approximately equal to 100 kg, and in a single or divided dose of 280 mg every two weeks in patients weighing more than 100 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

772. The method of embodiment 771 wherein the psoriasis is plaque psoriasis.

773. The method of embodiment 772 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

774. The method of embodiment 773 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

775. The method of embodiment 773, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

776. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 140 mg every two weeks when patients weigh less than or approximately equal to 110 kg, and in a single or divided dose of 280 mg every two weeks patients weighing more than 110 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

777. The method of embodiment 776 wherein the psoriasis is plaque psoriasis.

778. The method of embodiment 777 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

779. The method of embodiment 778 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

780. The method of embodiment 778, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

781. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 280 mg every four weeks when patients weigh less than or approximately equal to 90 kg, and in a single or divided dose of 210 mg every two weeks patients weighing more than 90 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

782. The method of embodiment 781 wherein the psoriasis is plaque psoriasis.

783. The method of embodiment 782 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

784. The method of embodiment 783 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

785. The method of embodiment 783, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

786. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/ml antibody in

- 126 040869 in a single or divided dose of 280 mg every four weeks when the weight of patients is less than or approximately equal to 100 kg, and in a single or divided dose of 210 mg every two weeks in patients weighing more than 100 kg, where the specified antibody or its binding IL- The 17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1 and a light chain sequence containing SEQ ID NO: 2.

787. The method of embodiment 786 wherein the psoriasis is plaque psoriasis.

788. The method of embodiment 787 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

789. The method of embodiment 788 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

790. The method of embodiment 788, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

791. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 280 mg every four weeks when patients weigh less than or approximately equal to 110 kg, and in a single or divided dose of 210 mg every two weeks patients weighing more than 110 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

792. The method of embodiment 791 wherein the psoriasis is plaque psoriasis.

793. The method of embodiment 792 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

794. The method of embodiment 793 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

795. The method of embodiment 793, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

796. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 280 mg every four weeks when patients weigh less than or approximately equal to 90 kg, and in a single or divided dose of 280 mg every two weeks patients weighing more than 90 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

797. The method of embodiment 796 wherein the psoriasis is plaque psoriasis.

798. The method of embodiment 797 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

799. The method of embodiment 798 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

800. The method of embodiment 798, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

801. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, and 140 mg/mL antibody in a single or divided dose of 280 mg every four weeks when patients are underweight

- 127 040869 or approximately equal to 100 kg, and in a single or divided dose of 280 mg every two weeks in patients weighing more than 100 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

802. The method of embodiment 801 wherein the psoriasis is plaque psoriasis.

803. The method of embodiment 802 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

804. The method of embodiment 803 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

805. The method of embodiment 803, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

806. A method for treating psoriasis in adult and/or juvenile patients with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose of 280 mg every four weeks when patients weigh less than or approximately equal to 110 kg, and in a single or divided dose of 280 mg every two weeks patients weighing more than 110 kg, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

807. The method of embodiment 806 wherein the psoriasis is plaque psoriasis.

808. The method of embodiment 807 wherein the plaque psoriasis is moderate to severe plaque psoriasis.

809. The method of embodiment 808 wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis and said patients are candidates for systemic therapy or phototherapy.

810. The method of embodiment 808, wherein the moderate to severe plaque psoriasis is chronic moderate to severe plaque psoriasis, and wherein said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and phototherapy with psoralen and ultraviolet radiation-A.

811. A pharmaceutical composition containing an aqueous solution of a buffer based on glutamic acid and an antibody containing a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, A light chain CDR1 comprising SEQ ID NO: 9, a light chain CDR2 comprising SEQ ID NO: 10, and a light chain CDR3 comprising SEQ ID NO: 11, wherein said antibody or fragment thereof specifically binds human IL-17 receptor A, and wherein :

a) said glutamic acid buffer contains glutamic acid at a concentration of 5-30±0.2 mM;

b) said glutamic acid buffer has a pH of 4.5-5.2±0.2;

c) said composition further comprises 2-4% w/v proline and 0.005-0.02% w/v polysorbate 20;

d) said antibody is present at a concentration of 100 to 150 mg/ml.

812. The pharmaceutical composition of claim 1, wherein the antibody or fragment thereof comprises a heavy chain variable domain sequence comprising SEQ ID NO: 3 and a light chain variable domain sequence comprising SEQ ID NO: 4.

813. The pharmaceutical composition according to claim 1, where the antibody contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2, or, alternatively, a heavy chain sequence containing SEQ ID NO: 12, and a light chain sequence containing SEQ ID NO: 2.

814. A pharmaceutical formulation according to embodiment 811 wherein the concentration of glutamic acid buffer or acetic acid buffer is 10±0.2 mM.

815. A pharmaceutical formulation according to embodiment 811, wherein the formulation has a pH of 4.8 ± 0.2.

816 A pharmaceutical formulation according to embodiment 811 having an isotonic or substantially isotonic osmolarity between 250 and 400 Osm.

817. Pharmaceutical formulation according to embodiment 811, having an isotonic

- 128 040869 or practically isotonic osmolarity from 275 to 325 Osm.

818. A pharmaceutical formulation according to embodiment 811 having an osmolarity of approximately 300 Osm/L.

819 Pharmaceutical formulation according to embodiment 811 containing 100-200 mg/mL AM-14 formulated with 5-15 mM glutamic acid, 7-9% w/v sucrose, 0.005-0.02 w/v .% polysorbate 20, pH 4.5-5.5±0.2.

820. Pharmaceutical formulation according to embodiment 811 containing approximately 140 mg/mL AM-14 formulated with 10 ± 0.2 mM glutamic acid, 8 ± 0.2 w/v% sucrose, 0.01 ± 0.002 wt./vol.% polysorbate 20, pH 4.8±0.2.

821. Pharmaceutical formulation according to embodiment 811 containing 100-200 mg/mL AM-14 formulated with 5-15 mM glutamic acid, 1-3% w/v glycine, 0.005-0.02 w/v vol.% polysorbate 20, pH 4.5-5.5±0.2.

822. Pharmaceutical formulation according to embodiment 811 containing approximately 140 mg/mL AM-14 formulated with 10 ± 0.2 mM glutamic acid, 2 ± 0.2% w/v glycine, 0.01 ± 0.002 wt./vol.% polysorbate 20, pH 4.8±0.2.

823. Pharmaceutical formulation according to embodiment 811 containing 100-200mg/mL AM-14 formulated with 5-15mM glutamic acid, 2-4% w/v proline, 0.005-0.02w/w vol.% polysorbate 20, pH 4.5-5.5±0.2.

824. Pharmaceutical formulation according to embodiment 811 containing approximately 140 mg/mL AM-14 formulated with 10 ± 0.2 mM glutamic acid, 3 ± 0.2% w/v L-proline, 0.01 ±0.002% w/v polysorbate 20, pH 4.8±0.2.

825. Pharmaceutical formulation according to embodiment 811 containing 100-200 mg/mL AM-14 formulated with 5-15 mM acetic acid, 1-3 w/v% glycine, 0.005-0.02 wt. /vol.% polysorbate 20, pH 4.5-5.5±0.2.

826. Pharmaceutical formulation of Embodiment 81 containing approximately 140 mg/mL AM-14 formulated with 10 ± 0.2 mM acetic acid, 2 ± 0.2% w/v glycine, 0.01 ± 0.002 wt./vol.% polysorbate 20, pH 4.8±0.2.

827. Pharmaceutical formulation according to embodiment 811 containing 100-200 mg/ml AM-14 formulated with 5-15 mM acetic acid, 2-4% w/v proline, 0.005-0.02 w/w vol.% polysorbate 20, pH 4.5-5.5±0.2.

828. Pharmaceutical formulation according to embodiment 811 containing approximately 140 mg/mL AM-14 formulated with 10 ± 0.2 mM acetic acid, 3 ± 0.2% w/v L-proline, 0.01 ±0.002% w/v polysorbate 20, pH 4.8±0.2.

829. Pharmaceutical formulation according to embodiment 811 containing 100-200 mg/ml AM-14 formulated with 5-15 mM acetic acid, 7-9% w/v sucrose, 0.005-0.02 w/v vol.% polysorbate 20, pH 4.5-5.5±0.2.

830. Pharmaceutical formulation according to embodiment 811 containing approximately 140 mg/mL AM-14 formulated with 10 ± 0.2 mM acetic acid, 8 ± 0.2% w/v sucrose, 0.01 ± 0.002 wt./vol.% polysorbate 20, pH 4.8±0.2.

831. Pharmaceutical formulation according to embodiment 811 containing 100-200 mg/ml AM-14 formulated with 5-15 mM acetic acid, 2-4% w/v glycerol, 0.005-0.02 w/w vol.% polysorbate 20, pH 4.5-5.5±0.2.

832. Pharmaceutical formulation according to embodiment 811 containing approximately 140 mg/mL AM-14 formulated with 10 ± 0.2 mM acetic acid, 3 ± 0.2% w/v glycerol, 0.01 ± 0.002 wt./vol.% polysorbate 20, pH 4.8±0.2.

833. Pharmaceutical formulation according to embodiment 811 containing 100-200 mg/ml AM-14 formulated with 5-15 mM acetic acid, 3.5-5.5% w/v sorbitol, 0.005-0, 02% w/v polysorbate 20, pH 4.5-5.5±0.2.

834. Pharmaceutical formulation according to embodiment 811 containing approximately 140 mg/ml AM-14 formulated with 10 ± 0.2 mM acetic acid, 4.5 ± 0.2% w/v sorbitol, 0.01 ±0.002% w/v polysorbate 20, pH 4.8±0.2.

835. A pharmaceutical formulation according to any one of embodiments 811-834, wherein said formulation has a viscosity of 4 to 10 centipoise at 25°C.

836. A pharmaceutical formulation according to any one of embodiments 811-834, wherein said formulation has a viscosity of 5 to 7 centipoise at 25°C.

837. A method for preparing a pharmaceutical composition, comprising combining an aqueous solution of a glutamic acid buffer or an acetic acid buffer and an isolated antibody or its IL-17RA binding fragment containing a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, Heavy chain CDR3 containing SEQ ID NO: 8, Light chain CDR1 containing SEQ ID NO: 9, Light chain CDR2 containing

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SEQ ID NO: 10, and a light chain CDR3 comprising SEQ ID NO: 11, wherein said antibody specifically binds human IL-17 receptor A and wherein:

a) said aqueous solution of glutamic acid buffer or acetic acid buffer has a pH of 4.5 to 5.2 ± 0.2;

b) said glutamic acid buffer or acetic acid buffer contains glutamic acid or acetic acid at a concentration of 5 to 30±0.2 mM;

c) said composition contains an excipient selected from the group consisting of sucrose, glycine, proline, glycerol and/or sorbitol at a concentration of from 1 to 20±0.2% w/v; And

d) the specified antibody is contained in a concentration of from 100 to 200 mg/ml.

838. A pharmaceutical container containing a container and an aqueous solution of a pharmaceutical composition according to any one of embodiments 811-836.

839. A pharmaceutical container according to embodiment 838, where the container is a vial, bottle, or pre-filled syringe.

840. A kit containing one or more pharmaceutical containers according to embodiment 838 and instructions for their use.

841. A method of treating IL-17-related inflammation in a human patient in need thereof, comprising administering to the patient a single or divided dose of 70 to 1000 mg of a pharmaceutical formulation according to any one of embodiments 811-836.

842. The method of embodiment 841 wherein the single or divided dose of the pharmaceutical composition of any of embodiments 811-836 is administered subcutaneously, intravenously, parenterally, intradermally, intramuscularly, and/or intraperitoneally.

843. The method of embodiment 841, wherein the single or divided dose of the pharmaceutical formulation of any of embodiments 811-836 is about 140 to 800 mg and is administered by subcutaneous injection, intradermal and/or intravenous injection.

844. A method of treating an IL-17-associated autoimmune disease in a human patient in need thereof, comprising administering to the patient a single or divided dose of 70 to 1000 mg of a pharmaceutical composition according to any one of embodiments 811-836 at least once every one up to six weeks.

845. The method of embodiment 844 wherein the single or divided dose of the pharmaceutical composition of any of embodiments 811-836 is administered subcutaneously, intravenously, parenterally, intradermally, intramuscularly, and/or intraperitoneally.

846. The method of embodiment 844, wherein the single or divided dose of the pharmaceutical composition of any of embodiments 811-836 is about 140 to 800 mg and is administered by subcutaneous injection, intradermal and/or intravenous injection.

847. A method of treating psoriasis in a human patient in need thereof, comprising administering to the patient a single or divided dose of 70 to 1000 mg of a pharmaceutical formulation according to any one of embodiments 811-836 at least once every one to six weeks.

848. The method of embodiment 847, wherein the single or divided dose of the pharmaceutical composition of any of embodiments 811-836 is administered subcutaneously, intravenously, parenterally, intradermally, intramuscularly, and/or intraperitoneally.

849. The method of Embodiment 847, wherein the single or divided dose of the pharmaceutical composition of any of Embodiments 811-836 is about 140 to 300 mg and is administered by subcutaneous injection, intradermal and/or intravenous injection.

850. The method of regulation of expression of one or more genes shown in table. 3.1, 3.2 and/or 3.3 in a patient with psoriasis, comprising administering to the patient an effective amount of AM-14.

851. The method of regulation of expression of one or more genes shown in table. 3.1, 3.2 and/or 3.3, in a patient with psoriasis and at the same time reducing the patient's PASI score by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75 , 80, 85, 90, 95, or 100%, comprising administering to the patient an effective amount of AM-14.

852. The method of regulation of expression of one or more genes shown in table. 3.1, 3.2 and/or 3.3, for 15 days or less in a patient with psoriasis and at the same time reduce the patient's PASI score by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 6θ , 65, 70, 75, 80, 85, 90, 95, or 100%, comprising administering to the patient an effective amount of AM-14.

853. The method of regulation of expression of one or more genes shown in table. 3.1, 3.2 and/or 3.3 in a patient with psoriasis, comprising administering an effective amount of an antibody that binds IL-17RA and prevents the activation of IL-17RA by one or more IL-17 ligands.

854. The method of regulation of expression of one or more genes shown in table. 3.1, 3.2 and/or 3.3, in a patient with psoriasis and at the same time reducing the patient's PASI score by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75 , 80, 85, 90, 95 or 100%, comprising the introduction of an effective amount of an antibody that binds IL-17RA and prevents the activation of IL-17RA by one or more IL-17 ligands.

- 130 040869

855. The method of regulation of expression of one or more genes shown in table. 3.1, 3.2 and/or

3.3, for 15 days or less in a patient with psoriasis and at the same time reduce the patient's PASI score by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75 , 80, 85, 90, 95 or 100%, comprising the introduction of an effective amount of an antibody that binds IL-17RA and prevents the activation of IL-17RA by one or more IL-17 ligands.

856. The method of regulation of expression of one or more genes shown in table. 3.1, 3.2 and/or 3.3 in a patient with psoriasis, comprising administering an effective amount of a monoclonal antibody that specifically binds human IL-17A.

857. The method of regulation of expression of one or more genes shown in table. 3.1, 3.2 and/or 3.3, in a patient with psoriasis and at the same time reducing the patient's PASI score by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75 , 80, 85, 90, 95, or 100%, comprising administering an effective amount of a monoclonal antibody that specifically binds human IL-17A.

858. The method of regulation of expression of one or more genes shown in table. 3.1, 3.2 and/or 3.3 in a patient with psoriasis and simultaneously reducing the patient's PASI score by at least 50%, comprising administering an effective amount of a monoclonal antibody that specifically binds human IL-17A.

859. The method of regulation of expression of one or more genes shown in table. 3.1, 3.2 and/or 3.3 in a patient with psoriasis and simultaneously reducing the patient's PASI score by at least 75%, comprising administering an effective amount of a monoclonal antibody that specifically binds human IL-17A.

860. The method of regulation of expression of one or more genes shown in table. 3.1, 3.2 and/or 3.3 in a patient with psoriasis, comprising administering to the patient an effective amount of AM-14.

861. Method of regulation of expression of one or more genes shown in table. 3.1, 3.2 and/or 3.3, in a patient with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml of antibody in a single or divided dose, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3, containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 containing SEQ ID NO: 11, and where the specified antibody specifically binds the A IL receptor -17 people.

862. The method of regulation of expression of one or more genes shown in table. 3.1, 3.2 and/or 3.3, in a patient with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml of antibody in a single or divided dose, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence containing SEQ ID NO: 3, and a light chain variable domain sequence , containing SEQ ID NO: 4, and where the specified antibody specifically binds the A receptor A IL-17 person.

863. The method of regulation of expression of one or more genes shown in table. 3.1, 3.2 and/or 3.3, in a patient with psoriasis, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml of antibody in a single or divided dose, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

864. The method of regulation of expression of one or more genes shown in table. 3.1, 3.2 and/or 3.3 in a patient with psoriasis and at the same time reducing the patient's PASI score by at least 75%, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01 w/v% polysorbate 20, pH 4.8±0.2, and 140 mg/ml antibody in a single or divided dose, wherein said antibody contains a heavy chain CDR1 comprising SEQ ID NO: 5, a heavy CDR2 chain containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 containing SEQ ID NO: 11, and wherein said antibody specifically binds human IL-17 receptor A.

865. The method of regulation of expression of one or more genes shown in table. 3.1, 3.2 and/or 3.3 in a patient with psoriasis and at the same time reducing the patient's PASI score by at least 75%, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3% w/v L-proline, 0.01 wt./vol.% polysorbate 20, pH 4.8±0.2, and 140 mg/ml of antibody in a single or divided dose, where the specified antibody or its binding IL-17RA fragment contains the sequence of the variable domain of the heavy chain, containing SEQ ID NO: 3, and a light chain variable domain sequence containing SEQ ID NO: 4, and where the specified antibody specifically binds the human IL-17 receptor A.

866. The method of regulation of expression of one or more genes shown in table. 3.1, 3.2 and/or

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3.3 in a patient with psoriasis and at the same time reducing the patient's PASI score by at least 75%, which includes administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3 wt./vol.% L-proline, 0.01 wt./ vol.% polysorbate 20, pH 4.8±0.2, and 140 mg/ml antibody in a single or divided dose, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1, and a light chain sequence containing SEQ ID NO: 2.

867. The method of regulation of expression of one or more genes shown in table. 3.1, 3.2 and/or 3.3, for 15 days or less in a patient with psoriasis and at the same time reducing the patient's PASI score by at least 75%, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3 w/v .% L-proline, 0.01 w/v% polysorbate 20, pH 4.8 ± 0.2, and 140 mg/ml antibody in a single or divided dose, where the specified antibody contains a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a CDR3 light chain containing SEQ ID NO: 11, and where the specified antibody specifically binds the A receptor A IL-17 person.

868. The method of regulation of expression of one or more genes shown in table. 3.1, 3.2 and/or 3.3, for 15 days or less in a patient with psoriasis and at the same time reducing the patient's PASI score by at least 75%, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3 w/v .% L-proline, 0.01 wt./vol.% polysorbate 20, pH 4.8±0.2, and 140 mg/ml antibody in a single or divided dose, where the specified antibody or its binding IL-17RA fragment contains a heavy chain variable domain sequence comprising SEQ ID NO: 3; and a light chain variable domain sequence comprising SEQ ID NO: 4, and wherein said antibody specifically binds human IL-17 A receptor.

869. The method of regulation of expression of one or more genes shown in table. 3.1, 3.2 and/or 3.3, for 15 days or less in a patient with psoriasis and at the same time reducing the patient's PASI score by at least 75%, comprising administering to said patient a pharmaceutical composition containing 10 mM glutamic acid, 3 w/v .% L-proline, 0.01 wt./vol.% polysorbate 20, pH 4.8±0.2, and 140 mg/ml antibody in a single or divided dose, where the specified antibody or its binding IL-17RA fragment contains a heavy chain sequence containing SEQ ID NO: 1 and a light chain sequence containing SEQ ID NO: 2.

870. A pharmaceutical composition containing an aqueous solution of a buffer based on glutamic acid and an antibody containing a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, A light chain CDR1 comprising SEQ ID NO: 9, a light chain CDR2 comprising SEQ ID NO: 10, and a light chain CDR3 comprising SEQ ID NO: 11, wherein said antibody or fragment thereof specifically binds human IL-17 receptor A, and wherein :

a) said glutamic acid buffer contains glutamic acid at a concentration of 5-30±0.2 mM;

b) said glutamic acid buffer has a pH of 4.5-5.2±0.2;

c) said composition further comprises 2-4% w/v proline and 0.005-0.02% w/v polysorbate 20;

d) said antibody is present at a concentration of 100 to 150 mg/ml.

871. A pharmaceutical composition according to embodiment 870, wherein the antibody or fragment thereof comprises a heavy chain variable domain sequence comprising SEQ ID NO: 3 and a light chain variable domain sequence comprising SEQ ID NO: 4.

872. The pharmaceutical composition according to embodiment 870, wherein the antibody comprises a heavy chain sequence comprising SEQ ID NO: 1 and a light chain sequence comprising SEQ ID NO: 2, or alternatively a heavy chain sequence comprising SEQ ID NO: 12 and the sequence light chain containing SEQ ID NO: 2.

873. A pharmaceutical composition according to embodiment 870, further having an osmolarity of 275 to 325 osm.

874. A pharmaceutical composition according to embodiment 870, further having a viscosity of 5 to 7 centipoise at 25°C.

875. Pharmaceutical formulation according to embodiment 870 containing approximately 140 mg/ml of the indicated antibody formulated with 10±0.2 mM glutamic acid, 3±0.2% w/v L-proline, 0.01± 0.002% w/v polysorbate 20, pH 4.8±0.2.

876. A pharmaceutical composition according to embodiment 871 containing approximately 140 mg/ml of the indicated antibody formulated with 10±0.2 mM glutamic acid, 3±0.2% w/v L-proline, 0.01± 0.002% w/v polysorbate 20, pH 4.8±0.2.

877. A pharmaceutical formulation according to embodiment 872 containing approximately 140 mg/mL of said antibody formulated with 10±0.2 mM glutamic acid,

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3±0.2% w/v L-proline, 0.01±0.002% w/v polysorbate 20, pH 4.8±0.2.

878. A pharmaceutical container containing a container and a pharmaceutical composition according to any one of embodiments 880-877, where the container is a vial, bottle, pre-filled syringe, or pre-filled syringe for self-injection.

879. A kit containing one or more pharmaceutical containers according to embodiment 878 and instructions for their use.

880. A method of treating psoriasis in a human patient in need thereof, comprising administering to the patient a single or divided dose of 70 to 1000 mg of an antibody, wherein said antibody is selected from the group consisting of:

a) an antibody containing a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, CDR2 a light chain comprising SEQ ID NO: 10 and a light chain CDR3 comprising SEQ ID NO: 11, wherein said antibody or fragment thereof specifically binds human IL-17 A receptor;

b) an antibody comprising a heavy chain variable domain sequence comprising SEQ ID NO: 3 and a light chain variable domain sequence comprising SEQ ID NO: 4, wherein said antibody or fragment thereof specifically binds the human IL-17 A receptor; And

c) an antibody comprising a heavy chain sequence comprising SEQ ID NO: 1 and a light chain sequence comprising SEQ ID NO: 2, or alternatively a heavy chain sequence comprising SEQ ID NO: 12 and a light chain sequence comprising SEQ ID NO: 2.

881. The method of embodiment 880, wherein said patient is administered a single or divided dose of 70 to 280 mg of said antibody administered at time 0 (first administration), one week after time 0 (first week), and then administered every two to four weeks after the first week of administration.

882. The method according to embodiment 881, wherein a single or divided dose of 140 mg of said antibody is administered at time 0 (first administration), one week after time 0 (first week), and then administered every two weeks when patients weigh less than or approximately equal to 100 kg, and where a single or divided dose of 280 mg of the indicated antibody is administered at time 0 (first administration), one week after time 0 (first week), and then administered every two weeks to patients weighing more than 100 kg.

883. The method according to any one of embodiments 880-882, wherein the psoriasis is selected from the group consisting of:

a) plaque psoriasis;

b) moderate to severe plaque psoriasis;

c) moderate to severe chronic plaque psoriasis and these patients are candidates for systemic therapy or phototherapy; And

d) Moderate to severe chronic plaque psoriasis, and where said patients are unresponsive, contraindicated, or intolerant of other systemic therapies, including cyclosporine, methotrexate, and psoralen and ultraviolet-A phototherapy.

884. The method according to any of embodiments 880-883, wherein said antibody is in a pharmaceutical composition containing approximately 140 mg/mL of said antibody formulated with 10±0.2 mM glutamic acid, 3±0.2 wt./ vol.% L-proline, 0.01±0.002% w/v polysorbate 20, pH 4.8±0.2.

885. The method of embodiment 884 wherein the pharmaceutical formulation is administered subcutaneously, intradermally, intramuscularly, and/or intravenously.

Table A

AM-14 sequences

Full length heavy chain AM-14 SEQ ID NO:1 QVQLVQSGAEVKKPGASVKVSCKASGYTFT RYGISWVRQAPGQGLEWMGWISTYSGNTNYAQKLQ GRVTMT T DT S T S TAYME LRS LRS DDTAVYYCARRQ LYFDYWGQGTLVTVSSASTKGPSVFPLAPCSRSTS ESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFP AVLQSSGLYSLSSWTVPSSNFGTQTYTCNVDHKP SNTKVDKTVERKCCVECPPCPAPPVAGPSVFLFPP KPKDTLMISRTPEVTCVWDVSHEDPEVQFNWYVD GVEVHNAKTKPREEQFNSTFRWSVLTWHQDWLN GKEYKCKVSNKGLPAPIEKTISKTKGQPREPQVYT LPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNG QPENNYKTTPPMLDSDGSFFLYSKLTVDKSRWQQG NVFSCSVMHEALHNHYTQKSLSLSPGK

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Examples

Example 1 AM-14 Formulations

Numerous formulations were prepared using a laboratory UF/DF (ultrafiltration/diafiltration) system at room temperature to identify excipients and formulations that are the only ones suitable for AM-14. UF/DF buffers were prepared at lower pH (3.5, 3.8 or 4.0) with glutamic acid or acetic acid buffers and various excipients including sucrose, L-proline, glycine, sorbitol, etc. .

Sample preparation from freeze-dried vials to reconstitute AM-14 at a higher concentration (180 mg/mL) was performed as follows: UF/DF final volume of purified bulk (FPB) AM-14 was prepared from a formulation of 70 mg/mL A52Su (10 mM acetic acid , 9% sucrose, pH 5.2) to approximately 90 mg/mL with a 5-fold increase in diafiltration volume (mL) for (a) 10 mM glutamate, 0.5% sucrose, pH 4.2, and b) 10 mM glutamate, 0.5% sucrose, pH 5.2, respectively. After UF/DF, the resulting concentrations for the above two conditions were 90.8 mg/ml at pH 5.33 for buffer (a) and 89.6 mg/ml at pH 5.63 for buffer (b), respectively. The AM-14 formulations were filtered through 0.45 micron filters and 1.25 ml were placed in ³ cc glass vials. The formulations were lyophilized. Samples prepared from buffer (a) are labeled E4.5 (i.e. 10 mM glutamate, pH 4.5) and samples from buffer (b) are labeled E5.5 (i.e. 10 mM glutamate, pH 4.5). pH 5.5). At room temperature, E4.5 vials were reconstituted with 0.685 ml of one of the diluents listed in Table 1. 1.0 and E5.5 vials were reconstituted with 0.596 ml of one of the diluents listed in Table. 1.0, which is about half of their original fill volume, yielding reconstituted formulations having a final glutamate concentration of 20 mM. After the lyophilized material was dissolved, the samples were ready for viscosity measurements.

The viscosity of the liquid protein formulations was measured using a cone/plate geometry rheometer (model RV III+, Brookfield Engineering Labs, Inc., Middleboro, MA).

The temperature of the sample was maintained at 25°C during the measurement using a water bath. The blade speed was varied from 15 to 125 rpm in increments of 10 rpm. Data collection was performed using Rheocalc™ software, version 2.7. Under each shear condition, 4 readings were taken at 10 s intervals, and each result was the average of the 4 readings. After establishing new shear conditions, the first reading was performed after a waiting time of 30 s. See table. 1.0 and 1.1. The results of measuring the viscosity for the compositions given in table. 1.0 were plotted as a function of shear stress and are shown in FIG. 1 and 2.

Referring to Table. 1.1, Formulation 1 having a final pH of 5.11 and Formulation 2 having a final pH of 3.33 showed significantly higher viscosities, while formulations having a pH of 4.55 to 4.93 had significantly lower viscosity, showing a clear optimum pH range in the highly concentrated AM-14 formulation, which provided lower viscosity.

Table 1.0

AM-14 concentrations at approximately 180 mg/ml_____

Recovery Buffer/pH Excipient Viscosity (cPs) Final pH value for AM-14 Transparency 10 mM glutamate, pH 4.5 4% sorbitol 19.64 5.24 transparent 10 mM glutamate, pH 4.5 200 mM PEG200 32.31 5.29 transparent 10 mM glutamate, pH 4.5 2.5% glycerol (271.5 mM) 18.29 5.24 transparent 10 mM glutamate, pH 4.5 3% proline (260 mM) 19.99 5.28 transparent 10 mM glutamate, pH 4.5 160 mm glutamine acid 12.50 4.98 transparent 10 mM glutamate, pH 4.5 200 mm creatinine 11.89 4.6 transparent 10 mM glutamate, pH 4.5 200 mM L-carnitine 12.85 4.8 transparent 10 mM glutamate, pH 4.5 50 mM creatinine + 70 mM NaCl 17.15 5.2 transparent

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10 mM glutamate, pH 4.5 50 mM creatinine +110 mM glutamic acid 12.77 4.9 transparent 10 mM glutamate, pH 4.5 80 mM arginine + 80 mM glutamine acid 14.85 5.05 transparent 10 mM glutamate, pH 4.5 130 mM proline + 70 mM NaCl 17.25 5.39 transparent 10 mM glutamate, pH 4.5 160 mM glycine 15.42 5.12 transparent 10 mM glutamate, pH 4.5 160 mM betaine 20.75 5.13 transparent 10 mM glutamate, pH 5.5 4% sorbitol 44.20 5.6 transparent 10 mM glutamate, pH 5.5 200 mM PEG200 39.45 5.6 transparent 10 mM glutamate, pH 5.5 2.5% glycerol (271.5 mM) 34.5 5.6 transparent 10 mM glutamate, pH 5.5 3% proline (260 mM) 27.3 5.65 transparent 10 mM glutamate, pH 5.5 160 mm glutamine acid 19.02 5.7 transparent 10 mM glutamate, pH 5.5 160 mM arginine-HC1, pH 5.5 15.74 5.7 transparent 10 mM glutamate, pH 5.5 200 mm creatinine 15.22 5.6 transparent 10 mM glutamate, pH 5.5 200 mM L-carnitine 18.07 5.6 transparent 10 mM glutamate, pH 5.5 50 mM creatinine + 70 mM NaCl 24.62 6.08 transparent 10 mM glutamate, pH 5.5 50 mM creatinine +110 mM glutamic acid 17.97 5.7 transparent 10 mM glutamate, pH 5.5 80 mM arginine + 80 mM glutamine acid 17.42 5.69 transparent 10 mM glutamate, pH 5.5 130 mM proline + 70 mM NaCl 15.88 5.76 turbid

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Table 1.1

Effect of pH on Viscosity for Highly Concentrated AM-14 Formulations

Compound Components composition Excipient Buffer buffer pH Final pH value Concentration, AM14 (mg/ml) Viscosity (cPs) 1.A48SuT acetic acid; sucrose, and polysorbate 20 sucrose Acetate 3.8 5.11 148.95 12.61 2.E44GT Glutamic acid, glycine, and polysorbate 20 Glycine L-glutamine acid 3.2 3.33 148 19.60 3.A48GT acetic acid, glycine, and polysorbate 20 Glycine Acetate 3.8 4.64 150.3 7.64 4. E40/48GT glutamic acid, glycine, polysorbate 20 Glycine L-glutamine acid 4 4.72 153.84 6.95 5.E52GT glutamine acid, glycine, polysorbate 20 Glycine L-glutamine acid 4.2 4.85 147.99 6.51 6. E48RT glutamine Proline L-glutamine 3.8 4.55 147.3 5.99 acid, proline, and polysorbate 20 acid 7. E52PT glutamic acid, proline, and polysorbate 20 Proline L-glutamine acid 4.2 4.93 147.88 6.69 8.E48ST glutamic acid, sorbitol, and polysorbate 20 Sorbitol L-glutamine acid 3.8 4.79 148.7 7.55 9.E44SuT glutamic acid, sucrose, and polysorbate 20 sucrose L-glutamic acid 3.2 4.66 148.55 7.61 10. E48SuT glutamine acid, sucrose, and polysorbate 20 sucrose L-glutamine acid 3.8 4.85 147.36 8.42 11. A48RT acetic acid, proline, and polysorbate 20 Proline Acetate 4.8 153.57 6.89

A separate study was conducted to investigate the relationship between viscosity and different concentrations of AM-14 in A52S (10 mM sodium acetate, pH 5.2, 5% sorbitol). In table. 1.2 shows that AM-14 was formulated at concentrations ranging from about 48 mg/mL to about 163 mg/mL. The effect on viscosity is shown in Fig. 3.

Table 1.2

Viscosity of AM-14 at various concentrations (see Fig. 3)_____

AM-14 concentration A52S (mg/ml) Density mPa*s 47.725 1.027807 1.5842 72.086 1.034805 2.2012 91.429 1.042012 3.4675 127.04 1.052502 9.3879 130.37 1.054458 12.1759 163.22 1.061677 27.9541

Separately, a study was made of the effect of pH on a highly concentrated formulation of AM-14. Kon

- 136040869 concentrations of AM-14 were approximately 200 mg/ml. Samples were prepared in a similar manner using a lyophilization process. The starting material was 70 mg/ml AM-14 in a buffer of 10 mM glutamate, pH 4.8, and 1% sucrose. 1.5 ml of starting material were placed in 3 cm ³ vials and then lyophilized. Each vial contained approximately 100 mg of AM-14. Received a series of solutions of 30 mm glutamate and 30 mm histidine at pH 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 and 6.5. 0.5 ml of these buffers were added to vials after lyophilization to obtain a material for measuring the viscosity, which corresponded to approximately 200 mg/ml, with various pH values. The effect of pH on the viscosity of AM-14 was determined and is shown in FIG. 4, which presents a subset of these data. These data demonstrate that the viscosity measured at 25°C in the case of a higher pH, such as pH above 5.7 (viscosity is >40 cP) is significantly higher than observed in the case of lower pH formulations (viscosity exceeds or equal to 20 cP).

Stability studies for AM-14 were performed using either a ³ cc glass vial or a 1 ml pre-filled glass syringe. The samples were stored at 4, 25, 29, 37, 40 and 45°C. Standard stability assays were used to monitor the stability of AM-14 formulations, including SE-HPLC, SEX-HPLC, HIAC (particles invisible to the naked eye) and visual examination.

Table 1.3

Stability at 4°C (SE-HPLC analysis) in a pre-filled syringe

Sample 0 point in time 1 month 3 months decline SEC %MP 1 A48SuT 99.65 99.66 99.63 0.02 2 E44GT 45.63 40.96 41.65 3.98 3 A48GT 99.7 99.67 99.67 0.03 4 E4048GT 99.76 99.72 99.68 0.08 5 E52GT 99.7 99.7 99.68 0.02 6 E48PT 99.75 99.73 99.7 0.05 7 E52RT 99.71 99.71 99.7 0.01 8 E48ST 99.67 99.69 99.46 0.21 9 E44SuT 99.73 99.69 99.72 0.01 10 E48SuT 99.57 99.61 99.62 -0.05

Table 1.4

Stability at 25°C in a pre-filled syringe

Sample 0 Im 3m decline SE %MP 1 A48SuT 99.65 99.44 99.23 0.42 2 E44GT 45.63 2.6 1.76 43.87 3 A48GT 99.7 99.5 99.09 0.61 4 E4048GT 99.76 99.53 99.13 0.63 5 E52GT 99.7 99.58 99.23 0.47 6 E48RT 99.75 99.64 99.42 0.33 7 E52RT 99.71 99.63 99.45 0.26 8 E48ST 99.67 99.56 99.33 0.34 9 E44SuT 99.73 99.56 99.33 0.4 10 E48SuT 99.57 99.44 99.15 0.42

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Table 1.5

Freeze-thaw stability in a scaled-down study (1 L scale) with a speed-controlled freezer

Compound Excipient Buffer Initial pH value Final pH value Protein concentration Viscosity (25C) T=0 After 2 freeze/defrost PO mg/ml AM-14 included in formulation with 10 mM glutamate, 8.5% sucrose and 0.01% polysorbate 20 sucrose L- glutamic acid 3.8 4.8 By 3.56 99.77 99.79 150 mg/ml AM-14 included in formulation with 10 mM glutamate, 8.0% sucrose and 0.01% polysorbate 20 sucrose L- glutamic acid 3.8 4.8 140 6.7 99.73 99.71 150 mg/ml AM-14 included in composition with 10 mM glutamate, 3% proline and 0.01% polysorbate 20 Proline L- glutamic acid 4 4.8 140 4.74 99.73 99.7

Based on these data, embodiments of AM-14 formulations include:

100-150mg/ml AM-14 formulated with 5-15mM glutamic acid, 7-9w/v% sucrose, 0.003-0.02w/v% polysorbate 20, pH 4.5 -5.5 ± 0.2, such as 140 mg/ml AM-14 formulated with 10 mM glutamic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20 , pH 4.8±0.2;

100-150mg/ml AM-14 formulated with 5-15mM glutamic acid, 1-3% w/v glycine, 0.003-0.02% w/v polysorbate 20, pH 4.5 -5.5 ± 0.2, such as 140 mg/ml AM-14 formulated with 10 mM glutamic acid, 2% w/v glycine, 0.01% w/v polysorbate 20 , pH 4.8±0.2;

100-150mg/ml AM-14 formulated with 5-15mM glutamic acid, 2-4% w/v proline, 0.003-0.02% w/v polysorbate 20, pH 4.5 -5.5±0.2, such as approximately 140 mg/ml AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v. % polysorbate 20, pH 4.8±0.2, and 140 mg/ml AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01 w/v. % polysorbate 20, pH 4.8±0.2;

100-150mg/ml AM-14 formulated with 5-15mM acetic acid, 1-3w/v% glycine, 0.003-0.02w/v% polysorbate 20, pH 4.5 -5.5 ± 0.2, such as 140 mg/ml AM-14 formulated with 10 mM acetic acid, 2% w/v glycine, 0.01 w/v% polysorbate 20 , pH 4.8±0.2;

100-150mg/ml AM-14 formulated with 5-15mM acetic acid, 2-4% w/v proline, 0.003-0.02% w/v polysorbate 20, pH 4.5 -5.5 ± 0.2, such as 140 mg/ml AM-14 formulated with 10 mM acetic acid, 3% w/v L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2;

100-150mg/ml AM-14 formulated with 5-15mM acetic acid, 7-9w/v% sucrose, 0.003-0.02w/v% polysorbate 20, pH 4.5 -5.5 ± 0.2, such as 140 mg/ml AM-14 formulated with 10 mM acetic acid, 8 w/v% sucrose, 0.01 w/v% polysorbate 20 , pH 4.8±0.2;

100-150mg/ml AM-14 formulated with 5-15mM acetic acid, 2-4% w/v glycerol, 0.003-0.02% w/v polysorbate 20, pH 4.5 -5.5 ± 0.2, such as 140 mg/ml AM-14 formulated with 10 mM acetic acid, 3% w/v glycerol, 0.01 w/v% polysorbate 20 , pH 4.8±0.2;

100-150 mg/ml AM-14 formulated with 5-15 mM acetic acid, 3.5-5.5% w/v sorbitol, 0.003-0.02% w/v polysorbate 20, pH 4.5-5.5±0.2, such as 140 mg/ml AM-14 formulated with 10 mM acetic acid, 4.5 w/v% sorbitol, 0.01 wt. /vol.% polysorbate 20, pH 4.8±0.2;

100-150mg/ml AM-14 formulated with 5-15mM glutamic acid, 7-9w/v% sucrose, 0.003-0.02w/v% polysorbate 20, pH 4.5 -5.5±0.2, 4-10 cP at 25°C, such as 140 mg/ml AM-14 formulated with 10 mM glutamic acid, 8 w/v% sucrose, 0. 01% w/v polysorbate 20, pH 4.8±0.2, 5-7 cP at 25°C;

100-150mg/ml AM-14 formulated with 5-15mM glutamic acid, 1-3% w/v glycine, 0.003-0.02% w/v polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25°C, such as 140 mg/ml

AM-14 formulated with 10 mM glutamic acid, 2 w/v% glycine, 0.01 w/v% polysorbate 20, pH 4.8±0.2, 5-7 cP at 25° WITH;

100-150mg/ml AM-14 formulated with 5-15mM glutamic acid, 2-4% w/v proline, 0.003-0.02% w/v polysorbate 20, pH 4.5 -5.5±0.2, 4-10 cP at 25°C, such as 140 mg/ml AM-14 formulated with 10 mM glutamic acid, 3 w/v% L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, 5-7 cP at 25°C;

100-150mg/ml AM-14 formulated with 5-15mM acetic acid, 1-3% w/v glycine, 0.003-0.02% w/v polysorbate 20, pH 4.5 -5.5±0.2, 4-10 cP at 25°C, such as 140 mg/ml AM-14 formulated with 10 mM acetic acid, 2 w/v% glycine, 0. 01% w/v polysorbate 20, pH 4.8±0.2, 5-7 cP at 25°C;

100-150mg/ml AM-14 formulated with 5-15mM acetic acid, 2-4% w/v proline, 0.003-0.02% w/v polysorbate 20, pH 4.5 -5.5±0.2, 4-10 cP at 25°C, such as 140 mg/ml AM-14 formulated with 10 mM acetic acid, 3 w/v% L-proline, 0.01% w/v polysorbate 20, pH 4.8±0.2, 5-7 cP at 25°C;

100-150mg/ml AM-14 formulated with 5-15mM acetic acid, 7-9% w/v sucrose, 0.003-0.02% w/v polysorbate 20, pH 4.5 -5.5±0.2, 4-10 cP at 25°C, such as 140 mg/ml AM-14 formulated with 10 mM acetic acid, 8 w/v% sucrose, 0. 01% w/v polysorbate 20, pH 4.8±0.2, 5-7 cP at 25°C;

100-150mg/ml AM-14 formulated with 5-15mM acetic acid, 2-4% w/v glycerol, 0.003-0.02% w/v polysorbate 20, pH 4.5 -5.5±0.2, 4-10 cP at 25°C, such as 140 mg/ml AM-14 formulated with 10 mM acetic acid, 3 w/v% glycerol, 0. 01% w/v polysorbate 20, pH 4.8±0.2, 5-7 cP at 25°C;

100-150mg/ml AM-14 formulated with 5-15mM acetic acid, 3.5-5.5% w/v sorbitol, 0.003-0.02% w/v polysorbate 20, pH 4.5-5.5±0.2, 4-10 cP at 25°C, such as 140 mg/ml AM-14 formulated with 10 mM acetic acid, 4.5 w/v .% sorbitol, 0.01 wt./vol.% polysorbate 20, pH 4.8±0.2, 5-7 cP at 25°C.

Example 2 Dosages and regimens for the treatment of inflammatory diseases in humans with anti-IL-17 A receptor monoclonal antibodies.

Preclinical pharmacokinetic and drug metabolism studies.

Pharmacokinetic studies included toxicology studies for one month and three months. AM-14 was quantified in cynomolgus monkey serum using a validated enzyme-linked immunosorbent assay (ELISA). Briefly, microplate wells were coated with mouse anti-AM-14 monoclonal antibody. Standards and quality control samples were prepared by adding AM-14 to 100% pooled cynomolgus monkey serum. AM-14 in standards, QCs, and test samples was captured with immobilized mouse anti-AM-14 monoclonal antibody, and then a second mouse anti-AM-14 monoclonal antibody conjugated with horseradish peroxidase (HRP) was added to bind to the captured AM- 14. The tetramethylbenzidine (TMB) substrate solution reacted with the peroxide and, in the presence of HRP, generated a colorimetric signal that was proportional to the amount of AM-14 bound by the capture antibody. Optical density was measured at 450 nm minus 650 nm. The data was simplified using a logistic (automatic estimation) regression model with a weighting factor of 1/Y ² . The nominal dynamic range in the analysis for 3 studies ranged from 50 to 2500 ng/ml.

Single dose pharmacokinetic study.

The pharmacokinetics were studied in a single dose pharmacokinetic study of AM-14 administered to male cynomolgus monkeys according to the purpose of IV (intravenous) or sc (subcutaneous) administration. 15 male cynomolgus monkeys were randomized into 5 groups (n=3 per group) and treated with 0.5 or 50 mg/kg AM-14 iv or 0.5, 5, or 50 mg/kg s.c. AM-14.

Serum concentration of AM-14 has been shown to increase with increasing dosing. After a single IV bolus, a 339-fold increase in AUC ₀ _ _inf was observed for a 100-fold increase in dose. Following s.c. doses ranging from 0.5 to 5 mg/kg, AM-14 exposure (both AUC ₀ _ _inf and C _max ) increased more than in proportion to the increase in dose. However, after SC doses ranging from 5 to 50 mg/kg, exposure increased approximately in proportion to the increase in dose (Table 2.1).

Since the pharmacokinetic profile of AM-14 was non-linear, it was necessary to further analyze the data using a compartmental approach, and thus the data were adjusted to a 2-compartmental model with Michaeles-Menten induction and an additional first-order elimination component.

The compartmental analysis performed (Table 2.2) estimated the first order clearance component at elimination as 1.78 ml/h, the maximum excretion rate (V _max ) as 34.4 µg/h, and Km as 0.984 µg/ml. When doses of AM-14 resulted in serum concentrations below 0.1 µg/mL (Km value,

- 139 040869 times approximately 0.1), the saturable excretion pathway was completely free and the kinetics could be considered linear. Similarly, when a dose of AM-14 resulted in serum concentrations greater than 10 μg/mL (approximately 10 times the _Kt ) for at least 3 to 4 half-lives, the saturable elimination component was negligible and the kinetics could also be consider linear. However, when the dose of AM-14 resulted in serum concentrations of 0.1 to 10 μg/mL, the non-linear component became significant and the elimination kinetics varied, depending on dose and dosing frequency; this was converted to various effective half-life values.

AM-14 exhibited non-linear pharmacokinetics after single i.v. or s.c. dosing in cynomolgus monkeys consistent with target driven displacement, and this was most pronounced after s.c. administration up to 5 mg/kg. After single or multiple s.c. doses ranging from 5 to 350 mg/kg, exposure increased approximately in proportion to dose. There was no significant difference in AM-14 exposure between sexes and moderate accumulation after multiple weekly dosing in cynomolgus monkeys for 1 or 3 months.

Table 2.1

Mean value (SD) for non-compartmental assessment of pharmacokinetic parameters after subcutaneous administration of a single dose of AM-14 to cynomolgus monkeys

Dose (mg/kg) tmax(i) Co or Stax (mcg/ml) AUCo-t (h»µg/mL) AUCo-inf (h µg/ml) C1 or C1/F (ml/h) _Vz or _Vz /F (ml) MRTo-inf (h) (n=3 per group) 0.5 in / in -- 9.79 (0.964) 160 (44.2) 168 (46) 8.33 (2.64) 142 (14.0) 18 (3.5) 0.5 p/c 27 1.28 (0.808) 69.7 (43.4) 74.2 (41) 22.2 (11.2) 681 (522) 45 (9.5) 5 p/c 72 20.7 (4.82) 3110 (1160) 3120 (1160) 4.70 (1.61) 98.7 (6.99) 110 (8.1) 50 I/V -- 673 (66.5) 56600 (18100) 57000 (18600) 2.33 (0.592) 75.2 (23.6) 140 (47) 50 p/c 72 166 (33.4) 33700 (10400) 33700 (10400) 3.98 (1.18) 72.2 (9.15) 150 (28)

Parameters are presented as mean (standard deviation [SD]) to 3 significant figures, except for t _max and MRTo. _in ft _ma x = time _Cmax after subcutaneous (s / c) administration; C _max = maximum observed serum concentration; C _o = estimated baseline concentration after intravenous (IV) bolus administration; AUC ₀ . _t = area under the concentration-time curve from time 0 to the last quantifiable concentration; AUCo-inf = AUC from time 0 to infinity; CL or CL / F = clearance calculated as dose / AuC (o-sh £), V _z or V _z / F = apparent volume of distribution, based on the terminal phase; MRT ₀ . _inf = mean time spent from time 0 to infinity.

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Table 2.2

Compartmental evaluation of pharmacokinetic parameters after single subcutaneous administration of AM-14 to cynomolgus monkeys

Parameter Description Value (SE%) θι Fn / _K bioavailability after s / c injection 0.977(7.2) 9,( ^4-1 ) K _ap / c, absorption rate constant for s / c injection 0.0267 (9.3) θ ₃ (h% K ₁₂ , the rate constant of distribution from the center to the periphery 0.0399 (20.6) θ4 (Η' ¹ ) Κ ₂ ι, distribution rate constant from the periphery to the center 0.0889 (18.5) θ ₅ (ml/h) CL, clearance of the first order 1.78 (15.8) 0 ₆ (µg/ml) K _t , maximum hatching speed 0.984 (23.6) 0 ₇ (µg/h) V _m , Michaeles-Menten constant 34.4(10.1) θ8 (ML) V, volume of distribution 224(15.1) σ ² ι proportional error variance 0.25 ² (13.4) σ ² ₂ additive error variance 99.1 ² (27.5)

sc = subcutaneous injection; SE = standard error.

Clinical effects of AM-14 in humans.

AM-14 was evaluated in two phase 1 clinical trials. 1 was a randomized, double-blind, placebo-controlled, incremental single dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AM-14 in healthy subjects and subjects with moderate to severe psoriasis. A single dose of AM-14 was administered at 7, 21, 70, 140, 210, 350, or 420 mg s.c. or 21, 210, or 700 mg i.v., as shown in Table 1. 2.3. This study was a two-part study in healthy individuals (Part A) and individuals with moderate to severe psoriasis (Part B). Healthy individuals were assigned to 1 of 8 sequential dosing groups and randomly assigned (3:1) to each group to receive a single SC or IV dose of AM-14 or placebo (Table 2.3). Individuals with moderate to severe psoriasis were assigned to 1 of 3 dosing groups and were randomly assigned to each group to receive a single IV or SC dose of AM-14 or placebo.

AM-14 was formulated with 10 mM sodium acetate, 9 w/v% sucrose and 0.004% polysorbate 20, pH 5.2 at a final concentration of 70 mg/mL.

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Table 2.3

Dose escalation sequence for study no. 1 (healthy individuals and individuals with moderate to severe psoriasis)

Part Group Dose/Route no. on AM- 14 no. on a placebo Description of individuals A 1 7 mg s.c. 6 2 healthy volunteer A 2 21 mg s.c. 6 2 healthy volunteer A 3 21 mg IV 3 1 healthy volunteer A 4 70 mg s.c. 6 2 healthy volunteer A 5 210 mg s.c. 6 2 healthy volunteer A 6 210 mg IV 4 ^a 1 healthy volunteer A 7 420 mg s.c. 6 2 healthy volunteer A 8 700 mg IV 6 2 healthy volunteer IN 9 700 mg IV 8 2 Moderate to severe psoriasis IN 10 140 mg s.c. 4 1 Moderate to severe psoriasis IN AND 350 mg s.c. 8 2 Moderate to severe psoriasis

i/v = intravenous administration;

sc = subcutaneous injection;

a The protocol lists 3 individuals with AM-14 for this group; however, 4 individuals with AM-14 were included.

Study no. 2 is a phase 1b, randomized, double-blind, placebo-controlled, escalating, multiple dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AM-14 in individuals with rheumatoid arthritis. Approximately 110 subjects received multiple SC and IV doses of AM-14 or corresponding placebo doses (Table 2.4). Individuals were randomly assigned 3:1 into groups 1-3 and 5 and 6.

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Table 2.4

Groups and dosing schedules for study no. 2 (rheumatoid arthritis)

Group No. Part Dose and route No. of individuals with active substance No. placebo individuals Total number of individuals 1 A 50 mg s.c. q2wks 6 2 8 2 A 140 mg s.c. q2wks 6 2 8 3 A 210 mg s.c. q2wks 6 2 8 4 IN Dose used in Part A 35 35 70 5 A 420 mg IV on days 1 and 29 6 2 8 6 A 700 mg IV on days 1 and 29 6 2 8 Total 65 45 BY

Pharmacodynamics of AM-14 in humans.

Two assays were included in clinical trials to measure pharmacodynamic responses to AM-14. The receptor occupancy assay allowed the assessment of target coverage, and ex vivo whole blood stimulation assay was used to evaluate functional blockade of IL-17R.

Receptor occupancy (RO) analysis.

Single dose in healthy individuals and individuals with psoriasis.

A semi-quantitative flow cytometric assay has been developed to measure IL-17 receptor expression in individuals to assess the biochemical coverage of AM-14 lymphocytes, monocytes, and granulocytes, where each cell type is easily identified by standard flow cytometric restriction techniques known in the art. Blood samples from individuals were collected on days -1, 1 (pre-dose), 3, 5, 8, or 15, 29, 43, 64, and 85. RO calculation was performed using IL-17R coverage by AM-14 (with competitively labeled antibody) in combination with total IL-17R expression (using a non-competitive anti-IL-17R antibody). The results of the mean percent RO in healthy volunteers administered doses of AM-14 from 21 to 700 mg are summarized in FIG. 5 and 6, respectively. Mean values for IL-17 AM-14 receptor occupancy on granulocytes from healthy volunteers are presented. These data demonstrate the biochemical uptake of the IL-17 receptor on whole blood granulocytes at different time points pre-dose (0) or post-dose AM-14 administered either subcutaneously (--) or intravenously (-) by the route. Receptor occupancy was calculated from baseline-normalized ratio of AM-14-PE (competitive anti-IL-17R mAb) to M204-PE (non-competitive anti-IL17R mAb) multiplied by 100%. Technical variability in the analysis at low occupancy levels can result in values below zero, which are arbitrarily placed on the x-axis. They include data for the 21 mg IV group (days 1, 8, 29, and 43) and the 210 mg IV and SC groups (day 64).

Results of mean percent RO in psoriasis patients treated with AM-14 doses of 21-700 mg are summarized in FIG. 6. Mean values for IL-17 AM-14 receptor occupancy on granulocytes from patients with psoriasis are shown. These data demonstrate the biochemical uptake of the IL-17 receptor on whole blood granulocytes at different time points pre-dose (0) or post-dose. Receptor occupancy was calculated from baseline-normalized ratio of AM-14-PE (competitive anti-IL17R mAb) to M204-PE (non-competitive anti-IL-17R mAb) multiplied by 100%. Technical variability in the analysis at low occupancy levels can result in values below zero, which are arbitrarily placed on the x-axis. They include 2 results from the s.c. 140 mg group and 2 results from the s.c. 350 mg group.

Maximum coverage was observed at the first moment of sampling in all individuals at all dosage levels. Incomplete RO was observed on days 3 and 5 at dose levels of 7 and 21 mg s.c. Greater than 90% of the mean RO was achieved for the 21 mg IV dose level and in all groups administered AM-14 70 mg or more. A longer RO was seen with increasing dose levels of AM-14. More than 90% RO IL-17R was observed 5-29 days after administration in individuals who were administered 420 or 700 mg of AM-14 in a single dose. These data demonstrate that healthy volunteers and psoriasis patients had similar RO profiles when given equivalent doses of AM-14. There were no marked changes in the percentage of monocytes, granulocytes, lymphocytes, or subsets of lymphocytes including T cells, B cells, and natural killer cells.

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Multiple doses in individuals with RA.

Blood samples from individuals were collected on days -1, 1 (pre-dose), 3, 15, 43 and 85 and analyzed using semi-quantitative flow cytometric analysis.

The mean percent RO results in rheumatoid arthritis (RA) patients treated with increasing doses of AM-14 are summarized in FIG. 7. Of note, there were no differences between RA individuals and healthy volunteers in IL-17R expression levels or AM-14 binding to leukocytes based on comparative in vitro studies in these populations.

In FIG. 7 shows the mean IL-17 receptor occupancy on granulocytes in RA patients pre-dose (0) or post-dose AM-14. Receptor occupancy was calculated from the baseline normalized ratio of AM-14-PE (competitive anti-IL17R mAb) to M204-PE (non-competitive anti-IL-17R mAb). Technical variability in the analysis at low occupancy levels can result in values below zero, which are arbitrarily placed on the x-axis. These include day -1 in the 50 and 140 mg groups and day 1 in the 210 mg group.

The maximum RO of granulocytes by AM-14 was observed on the 3rd day after treatment for all dose levels. Patients included in group 1 (50 mg) showed a 95% RO on day 3 and an incomplete RO (32-39%) when the drug reached trough levels on days 15, 43 and 85. All patients in group 2 (140 mg) showed more than 95% RO on day 3 and more than 80% RO on day 15. At day 43, RO was greater than 90% in all patients, indicating some degree of accumulation of AM-14. Receptor occupancy remained above 90% in 5 of 6 patients at day 85, and all patients showed greater than 80% RO. Data up to day 15 for group 3 (210 mg) showed that patients showed more than 95% RO on day 3. There were no apparent changes in the percentage of monocytes, granulocytes, lymphocytes, or lymphocyte subgroups, including T cells, B cells, and natural killer cells in any of the AM-14 treated RA patient groups.

Stimulation analysis in whole blood.

Evaluation of the biological effects of AM-14 using ex vivo whole blood stimulation assay.

To demonstrate the functional biological effect of AM-14 on IL-17R signaling, a pharmacodynamic assay using human whole blood was developed and included in study no. 1. In this assay, human whole blood was collected before and after AM-14 dosing and then stimulated with TNF and titrated with IL-17 for 4 h. Cells were then lysed and then the lysate was analyzed for IL-17 responsive genes including IL-6 using a branched DNA (b-DNA) signal amplification assay. In the presence of AM-14, IL-6 mRNA induction was completely inhibited with an observed increase in EC ₅₀ for an IL-17 dependent increase in expression. These data can be quantified as the shift in IL-17 EC ₅₀ response from baseline to pre-dose levels for each patient.

The EC ₅₀ curves for IL-17 stimulation of IL-6 mRNA (as measured by b-DNA analysis) after a single dose of AM-14 were significantly shifted from pre-dose levels. Some level of functional blockade of signal transduction was noted in all healthy individuals administered AM-14 in group 4 (70 mg s.c.) on day 5 and in all healthy individuals administered AM-14 in groups 5 (210 mg s / c) 8 (700 mg / in) on the 15th day. In group 9 (700 mg iv), all 4 psoriasis individuals tested treated with AM-14 showed functional blockade on day 29 and 3 of 4 individuals showed blockade on day 43. The average shift log 10 EU ₅₀ for each group at the tested time points are presented in table. 2.5.

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Table 2.5

AM-14 results in functional blockade of IL-17 signaling in an ex vivo assay

Group Dose 30 ^minutes Day 5 ^a Day 8 ^a Day 15 ^a Day 29 ^a Day 43 ^a Day 64 ^a 1 7 mg s.c. -0.04 -0.27 -0.24 2 21 mg s.c. 0.22 0.22 0.35 3 21 mg IV 2.08 0.4 0.19 4 70 mg s.c. 1.32 0.91 -0.04 5 210 mg s.c. 2.35 1.22 -0.13 6 210 mg IV 2.49 2.09 -0.24 7 420 mg s.c. 2.1 2.12 0.15 8 700 mg IV 1.72 1.74 -0.99 9 700 mg IV 1.95 1.46 10 140 mg s.c. 0.45 0.27 eleven 350 mg s.c. 2.02 0.45 placebo ^b 0.03 -0.08 0.19 0 0.04 0.27 0.05

^a The log EC ₅₀ shift was calculated for the post-dose sample minus the mean log EC ₅₀ of the two pre-dose samples per individual. The mean log EC ₅₀ shift is shown for 3 to 6 subjects studied in each group.

^b Mean value for placebo samples in all groups taken at the same time point post-dose.

Competitive Antagonism Model for Stimulation Data in Whole Blood

Preliminary pharmacokinetic/pharmacodynamic analyzes using a competitive antagonist model allowed modeling the effects of AM-14 on IL-17R function from an ex vivo whole blood stimulation assay (WBS). The dissociation constant (Ki) was estimated to be 51 ng/ml, and the IC ₅₀ and IC ₉₀ levels of AM-14 for IL-17R inhibition were estimated to be in the ranges of about 130-540 and about 2860-15600 ng/ml, respectively, when IL-17 concentration was expected to be in the range of 0.5-50 ng/mL.

Pharmacokinetics of AM-14 in humans.

Serum pharmacokinetics for a single dose in healthy individuals and individuals with psoriasis.

Pharmacokinetic data for a single IV and SC dose of AM-14 were obtained for healthy individuals in groups 1 to 8 and in individuals with psoriasis in groups 9-11. Serum AM-14 concentrations were not detected in any of the group 1 samples (7 mg s.c.) or most of the group 2 samples (21 mg s.c.). Serum AM-14 concentration versus time profiles for all other groups of healthy volunteers showed non-linear pharmacokinetics and exposure (as assessed by the maximum observed concentration [C _max ] and the area under the concentration-time curve from time 0 to the last quantifiable concentration [AUC ₀ .t]) increased more than dose proportionally (Table 2.6). Following s.c. administration of 70, 210, or 420 mg, the median time to C _max (t _max ) was in the range of 48-168 hours. The apparent bioavailability after s.c. administration was estimated to be approximately 70% based on simultaneous pharmacokinetic modeling of all data. s / c and / in groups. Pharmacokinetic parameters for i.v. dosing of 700 mg in individuals with psoriasis were found to be comparable to those in healthy volunteers based on a direct comparison of concentration-time curves for 700 mg i.v. in healthy volunteers and individuals with psoriasis (group 8 and group 9). Two separate biomarker assays were performed to determine the biological activity of AM-14 in whole blood, including receptor occupancy and functional blockade of the IL-17 receptor, as described above. Both assays demonstrated a direct relationship between serum AM-14 concentrations and functional data from these assays, including target coverage (IL-17R) and log EC ₅₀ shift measured in whole blood stimulation assay. Samples with measurable circulating AM-14 consistently showed IL-17 receptor occupancy and an increase in log EC50, with higher shifts at higher concentrations.

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Table 2.6

Mean value (SD) of AM-14 pharmacokinetic parameters in healthy volunteers (groups 1-8) and individuals with psoriasis (groups 9-11)

Group Dose and route (mg) Tmax ( ^h ) _Cmax (µg/ml) AUCo-t (µg»h/ml) 1(HV) 7 p/c NC NC NC 2 (HV) 21 p/c NC NC NC 3(HV) 21 in / in 0.6 (0.6-4.0) 6.67 (2.11) 238 (78.9) 4 (HV) 70 p/c 48 (48-96) 2.54(1.37) 313 (213) 5 (HV) 210 p/c 96(72-96) 10.6(8.93) 2790 (2740) 6(HV) 210 I/O 0.7 (0.6-0.7) 63.9(12.6) 8280 (1440) 7(HV) 420 p/c 168 (96-168) 23.6(5.37) 9360 (2550) 8 (HV) 700 I/O 0.7 (0.7-0.8) 159(29.5) 36000 (8850) 9 (Pso) 700 I/O 2.0 (0.5-4.0) 198 (39.6) 39800 (8610) 10(PsO) 140 p/c 48 (48-48) 5.47 (3.00) 631 (347) ll ^a (PsO) 350 p/c 168(48-168) I,5 (5.72) 3030 (1980).

a For group 11, data are only partially available.

C _max and AUC _0-t are presented as mean (SD) values, while t _max is presented as a median (range).

All values were rounded to three significant figures after calculations, with the exception of tmax.

AUC _0-t = area under the concentration-time curve from time 0 to the last quantifiable concentration;

C _max = maximum observed concentration;

t _max = time at observed maximum concentration;

NC = not calculated due to the fact that most of the samples were below the limit of quantitation;

HV = healthy volunteer;

PsO = individual with psoriasis.

Serum pharmacokinetics for multiple doses in individuals with RA.

Preliminary pharmacokinetic data for multiple sc doses of AM-14 were obtained from individuals with RA in a phase 1b study. Serum AM-14 concentration data were available through the end of the study for all group 1 individuals (50 mg every 2 weeks) and up to 85 days for most group 2 individuals (140 mg every 2 weeks). AM-14 exhibited non-linear pharmacokinetics in RA individuals and exposure (estimated by C _max and AUC _0-t ) after the first and last (6th) sc dose increased more than dose proportionally at the 50-140 mg dose (Table 1). 2.7). The median t _max ranged from 36 to 96 hours. Minimal accumulation was observed after 6 doses of 50 mg administered sc every 2 weeks, while accumulation was minimal after 140 mg administered every 2 weeks. The pharmacokinetics of AM-14 after the first s.c. dose of 140 mg in RA subjects appeared to be comparable to the pharmacokinetics after a single s.c. dosing of 140 mg in individuals with psoriasis (group 10; C _max = 5.47 ± 3.00 μg / ml, AUC _0.t =631±347 µg-h _/ ml).

Table 2.7

Mean value (SD) of AM-14 pharmacokinetic parameters in individuals with RA (groups 1 and 2)

Group Dose and route Phase Tmax ( ^h ) C _max (MKG/ML) AUCo-t (mg) (µg»h/ml) 1 50 p/c q2w 1st dose 36.0 (40-48.0) 0.742 (0.522) 41.6 (38.6) 6th dose 48.0 (24.0-48.0) 1.35 (1.07) 95.9 (73.7) 2 140 p/c q2w 1 dose 96.0 (48.0-96.0) 5.67 (2.98) 864 (668) 6th dose 96.0 (48.0-96.0) 5.93 (5.15) 1200 (1240)

C _max and AUC _0-t are shown as mean (SD) values, while t _max is shown as the median (range).

All values were rounded to 3 significant digits after calculations, except for t _max which is represented to one decimal digit.

AUCo _-t = area under the concentration-time curve from time 0 to the last quantifiable concentration;

C _max = maximum observed concentration;

q2w = every 2 weeks;

tmax = time at observed maximum concentration.

^a For the last dose of group 2, only partial data are available.

The results of the study in psoriasis.

healthy individuals were included in groups 1-8; 43 individuals were administered AM-14 and 14 individuals were administered placebo. 25 individuals with moderate to severe psoriasis were included in groups 9-11. In group 9, 8 individuals were administered AM-14 and 2 individuals were administered placebo; in group 104 individuals were administered AM-14 and 1 individual was administered placebo, and in group 11 8 individuals were administered AM-14 and 2 individuals were administered placebo.

PASI scores for all individuals with psoriasis (A-J) in group 9 to day 85 (end of study) are shown in Table 1. 2.8. PASI scores for all individuals with psoriasis (A-E) in group 10 to day 85 (end of study) are presented in Table. 2.10. PASI scores for all individuals with psoriasis (A-J) in group 11 to day 85 (end of study) are shown in Table 1. 2.11.

In group 9 (700 mg IV), the maximum effects of PASI were observed on day 43, when 7 of 8 (88%) individuals administered AM-14 experienced a 75% reduction in PASI score (PASI 75) (Table 2.8) . All AM-14 treated individuals in group 9 achieved a PASI 50 (50% reduction) by day 29, while none of the placebo treated individuals achieved a PASI 50 response at any time point. A PASI 90 response (90% reduction from baseline PASI) was observed in 3 of 8 (38%) individuals by day 43 who received 700 mg AM-14 IV (Tables 2.8 and 2.9). Compared to the high dose PsO (700 mg iv) group of individuals, the PASI responses for individuals treated with 140 and 350 mg of AM-14 administered subcutaneously were lower. As shown in Table. 2.10, only 1 of 4 individuals had a significant PASI response (>50%) in the 140 mg sc dose group, and this response disappeared by day 43. In the 350 mg sc group, 6 out of 8 and 5 out of 8 individuals achieved PASI 50 and PASI 75, respectively, during the study (Table 2.11).

There was a positive relationship between AM-14 dose and PASI 50/75/90 response among individuals treated with AM-14. None of the placebo-treated individuals achieved a PASI response of 50 or more at any time post-dose. The mean percentage increase in PASI increased with increasing dose of AM-14 up to 29 days. The 700 mg IV and 350 mg sc groups had a higher mean percentage increase in PASI scores than the placebo group at all time points post-dose. A total of 7 of 8 (88%) and 5 of 8 (63%) individuals in the 700 mg IV and 350 mg SC groups, respectively, achieved a PASI score of 75 or better. The 140 mg sc group had the highest mean percentage improvement in PASI scores than the placebo group up to day 29, with 2 of 4 individuals (50%) achieving a PASI 50 response at any time post-dose.

The mean improvement in PGA from baseline was greater in the 700 mg IV group compared to the placebo group at all time points; these differences were statistically significant (α=0.05) at all time points based on post hoc analyses, except for mean PGA improvement at day 85 (p=0.0510). Based on post hoc analyses, mean PGA improvement from baseline was significantly (α=0.05) higher in the 350 mg sc group compared to placebo at days 15 and 43; similar results were observed for the 140 mg s.c. group on day 15 (α=0.05).

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Table 2.8

PASI Group 9 responses

Group 9 PASI score A IN WITH- RVO D E F G N- RVO I J Before Dosing 17.4 15.2 26.2 11.6 11.0 16.0 12.6 11.8 12.5 12.1 15 day 6.6 6.1 17.8 5.2 6.4 7.8 5.0 8.4 2.7 2.9 Day 29 4.9 2.8 17.0 4.1 5.2 4.8 2.4 9.5 2.1 0.4 43 days 4.1 0.9 19.5 1.3 2.4 4.5 1.0 8.8 2.8 0.0 64 days 7.0 4.5 21.2 2.2 1.8 9.5 2.4 H.4 2.8 0.0 85 days 7.6 5.1 18.0 3.7 4.7 14.3 8.2 12.9 10.8 0.0 % reduction PASI A IN WITH- RVO D E F G N- RVO I J 15 day 62% 60% 32% 55% 42% 51% 60% 29% 78% 76% Day 29 72% 82% 35% 65% 53% 70% 81% 19% 83% 97% 43 days 76% 94% 26% 89% 78% 72% 92% 25% 78% 100% 64 days 60% 70% 19% 81% 84% 41% 81% 3% 78% 100% 85 days 56% 66% 31% 68% 57% eleven% 35% -9% 14% 100%

Table 2.9

PASI Response for Group 9 - Percentage Improvement Over Time by Administration Group

placebo AM-14 at a dose of 700 mg (iv) PASI response Moment of time n/N (%) n/N (%) > 50% 15 day 0/2(0) 7/8(88) Day 29 0/2(0) 8/8(100) 43 days 0/2(0) 8/8(100) 64 days 0/2(0) 7/8(88) 85 days 0/2(0) 4/8(50) > 75% 15 day 0/2(0) 2/8(25) Day 29 0/2(0) 5/8(63) 43 days 0/2(0) 7/8(88) 64 days 0/2(0) 4/8(50) 85 days 0/2(0) 1/8(13) > 90% 15 day 0/2(0) 0/8(0) Day 29 0/2(0) 1/8(13) 43 days 0/2(0) 3/8(38) 64 days 0/2(0) 1/8(13) 85 days 0/2(0) 1/8(13)

N = Number of individuals treated and assessed at each visit.

N = Number of respondents on each visit.

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Table 2.10

PASI Group 10 responses

Group 10 PASI score A IN WITH D E-RVO Before Dosing 12.6 15.4 10.5 11.0 16.8 15 day 12.0 I,6 5.2 8.1 17.2 Day 29 I,6 5.4 6.6 9.9 16.2 43 days 12.1 9.8 8.1 9.8 14.8 64 days 15.6 13.6 8.9 Yu,1 15.9 85 days 12.5 15.6 8.9 9.6 16.5 % reduction PASI A IN WITH D E-RVO 15 day 5% 25% 50% 26% -2% Day 29 8% 65% 37% 10% 4% 43 days 4% 36% 23% eleven% 12% 64 days -24% 12% 15% 8% 5% 85 days 1% -1% 15% 13% 2%

Table 2.11

PASI Group 11 responses

Index PASI for group 11 A IN WITH D-PBO E F G H I J-PBO Before Dosing 13.3 17.8 14.2 12.5 6.4 13.4 19.0 13.3 12.0 16.3 15 day 6.9 13.6 12.6 12.5 oh oh 3.4 9.2 4.0 4.0 11.7 Day 29 7.8 I,8 12.8 and about 2.4 0.4 7.2 2.8 2.1 I,7 43 days 10.4 7.8 14.4 10.7 1.0 7.5 4.8 4.8 2.0 12.7 64 days from 7.4 13.1 12.5 2.4 5.9 4.5 5.6 6.0 from 85 days By 12.2 14.0 12.5 2.4 6.2 7.6 5.2 5.8 12.6 % decline PASI A IN WITH D-PBO E F G N- RVO I J-PBO 15 day 48% 24% eleven% 0% 100% 75% 52% 70% 67% 28% Day 29 41% 34% 10% 12% 63% 97% 62% 79% 83% 28% 43 days 22% 56% -1% 14% 84% 44% 75% 64% 83% 22% 64 days 15% 58% 8% 0% 63% 56% 76% 58% 50% 31% 85 days 17% 31% 1% -2% 63% 54% 60% 61% 52% 23%

Results of a study in rheumatoid arthritis.

To date, all individuals in groups 1-3 (50, 140, and 210 mg s.c.) have completed the study. All 24 individuals included in groups 1-3 received concomitant administration of MTX (n=23) or leflunomide (n=1). To date, all individuals in Group 5 (420 mg IV) have completed dosing, and 6 of the 8 individuals in Group 6 (700 mg IV) are included. AM-14 was well tolerated at the doses tested (50, 140 and 210 mg s.c.).

Pharmacokinetic/pharmacodynamic modeling.

Compartmental pharmacokinetic modeling was performed on concentration data

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AM-14 time in healthy volunteers (groups 3-8). To describe the AM-14 concentration-time data, a two-compartmental model with parallel linear and non-linear excretion pathways and an additional sc absorption compartment was used. The non-linear elimination pathway was modeled by Michaeles-Menten kinetics resulting in a maximum elimination rate (V _max ) and a Michaeles-Menten constant (Km) of 1290 μg/day/mL (4% SE) and 14.9 ng/mL (270 % SE), respectively. The estimated human pharmacokinetic parameters were used to mimic concentration-time pharmacokinetic profiles and calculate exposures (AUC and C _max ) across a range of single and multiple IV and SC doses for a potential clinical trial. Single dose predictions compared well with subsequent available data for the psoriasis groups (groups 9-11). The predictions for multiple doses also compared well with the available data for groups 1 and 2 of the phase 1b trial, albeit with less concentration accumulation than expected for 140 mg every 2 weeks of dosing. In addition, the model also predicted well the pharmacokinetics of AM-14 in RA individuals in the phase 1b trial, indicating comparable pharmacokinetics of AM-14 among healthy and diseased populations (with both RA and psoriasis).

The relationship of pharmacokinetics / pharmacodynamics.

There was a monotonically increasing relationship between pEC ₅₀ shift measured in whole blood stimulation assay and circulating AM-14 concentration as measured by pharmacokinetic assay, as shown in FIG. 8. AM-14 concentration is located on the x-axis and pEC ₅₀ shift is located on the y-axis. Shift log EC ₅₀ measured on average relative to 2 baseline samples. The lower limit of quantification (LLOQ) for the PK assay was 50 ng/mL, and thus samples dosed below the LLOQ are plotted on the x-axis at 25 ng/mL and have log EC ₅₀ values generally below 2. The mean log EC ₅₀ shift for placebo samples is 0.02±0.6. Samples with measurable circulating AM-14 consistently show an increase in log EC ₅₀ with higher shifts at higher concentrations. Similar to placebo samples, the log EC50 shift for samples at low AM-14 concentrations below an LLOQ of 50 ng/mL is limited. The overall relationship is consistent with a competitive inhibition model between AM-14 and IL-17A.

Suggested AM-14 doses and dosing regimens are shown in FIG. 9 based on the simulation described above. The IC ₅₀ and IC ₉₀ levels for AM-14 are based on ex vivo whole blood stimulation assay data and use a competitive PK/PD antagonism model over the IL-17 concentration range of 0.5 to 50 ng/mL. IC _50/90 : Serum concentration of AM-14 that inhibits the increase in IL-6 mRNA by 50/90% in an ex vivo whole blood assay. The 70 mg dose (loaded at week 1) was expected to achieve an exposure above the IC ₅₀ level. Doses of 140 and 210 mg administered every 2 weeks (with an additional dose at 1 week) were expected to achieve continuous exposure within and above the expected IC ₉₀ range, respectively, during the study period. It was also expected that the dose of 280 mg given every 4 weeks would achieve an exposure within the expected IC ₉₀ range, but with minimal variation below the IC ₅₀ range.

Exposure limits were evaluated as the ratio of exposure in cynomolgus monkeys after dosing on day 78 at a dose of 90 mg/kg sc to the predicted exposure in humans in the stationary phase. The mean AUC _o _ ₁₆₈₄ and C _max after administration on day 78 in a toxicokinetic study in monkeys were 159,000 and 1180 μg/ml, respectively. The predicted steady state AUC ₀ _ _{336 h} after the third dose of 70, 140, or 210 mg administered every 2 weeks (with loading at week 1) was 552, 4320 and 8230 µg-h/mL, and the predicted AUC ₀ _ _{672 h} after the third and final dose of 280 mg administered every 4 weeks was 5280 mcg-h/ml. The 2-week limits based on AUC for predicted human exposure relative to exposure in toxicity studies for 70, 140, and 210 mg are 576, 74, and 39, respectively. For the 280 mg dose, the predicted limit at 4 weeks was 121.

Pharmacokinetic (PK) data (serum drug concentrations measured at predetermined time points) for AM-14 were obtained for each individual in study 1. Pharmacodynamic (PD) data (PASI score at baseline and at predetermined time points after administration doses) were also given to individuals in the final three groups (individuals diagnosed with moderate to severe plaque psoriasis). Modeling was performed on preliminary data to characterize the PK response in all individuals (based on the true administered dose) and to characterize the PD response (based on the individual PK response).

The data were found to fit best with a two-compartmental PK model with parallel linear and non-linear (Michaeles-Menten) elimination pathways and an additional subcutaneous dose compartment (see FIG. 10). Components of the variance characterizing interpatient variability as well as residual variability were included. To model PD, a peripheral effect area compartment was added to the model coupled to the indirect response model of inflammatory synthesis and degradation. Placebo absorption compartments and

- 150 040869 exposure over time to simulate placebo response over time. Key assumptions in the model included: inflammation was measured as a measure of PASI; drug concentrations in the effect area compartment inhibited inflammatory synthesis; the placebo effect acted to stimulate a reduction in inflammation for all individuals; and endogenous synthesis (rate) in inflammation occurred prior to dosing. Other PD models have also been explored, but found to be less than optimal. Nonlinear mixed effects software NONMEM VI (Icon Development Solutions, Ellicott City, Maryland, USA) was used to fit all models to the data.

In FIG. 11 compares the observed and predicted mean PASI response over time (as percentage change from baseline) after a single dose of AM-14 or placebo. This model characterizes the true PASI response data well. The mean maximum response for the highest dose (700 mg iv) had an improvement in PASI greater than 80%.

In FIG. 12 shows the mean PASI response over time for four multiple dose scenarios (over 12 weeks), including placebo effect, based on a model developed from single dose data. The simulated placebo response was assumed to be effective after only the first dose, which is a conservative estimate. The median response for the 140 mg s.c. dose (at weeks 0, 1, 2, 4, 6, 8, 10) was expected to exceed the 50% improvement in PASI for most of the study period, including a preliminary efficacy result at week 12 (84 day). The mean response for s.c. doses of 210 and 280 mg (at 0, 1, 2, 4, 6, 8, 10 weeks) was expected to exceed the 75% improvement in PASI for most of the study period, including the primary efficacy outcome at week 12 ( 84 days). The predicted response for repeated dosing of 210 and 280 mg is similar to, but does not exceed in duration, that observed for a single IV dose of 700 mg, as shown in FIG. eleven.

In FIG. 13 shows the predicted dose responses at week 12 for the range of doses (mg sc) administered at weeks 0, 1, 2, 4, 6, 8 and 10 based on the dose response predicted in FIG. 12, on day 84 (week 12). Dose-response curves (with 90% CI) are shown for the mean PASI response at week 12 and the percentage of individuals expected to achieve PASI 50, 75, 90 at week 12.

Example 3 Gene regulation in psoriasis patients with an anti-IL-17 antagonist antibody.

The data presented below demonstrate that inhibition of IL-17R activation strongly influences gene regulation in patients with psoriasis. Thus, aspects of the invention include methods for regulating gene expression in patients with psoriasis using anti-IL-17 antagonist antibodies. An antagonist antibody against IL-17 is an antibody that inhibits activation by IL-17A or IL-17A/F of their recognized receptor(s), including IL-17RA, IL-17RC and IL-17RA/RC. Antagonist antibodies against IL-17 include antibodies against IL-17RA or antibodies against IL-17A and/or IL-17A/F.

In patients in Group 9 of Study 1 (see Example 2), pre-dose skin biopsies of 6 mm were taken from an area without injury and from an area of injury that was large enough to allow two subsequent adjacent biopsies after dosing. Two subsequent biopsies were taken two weeks and six weeks after AM-14 administration at predetermined positions in the lesion, regardless of the appearance of the skin in the lesion at the time of the biopsy. The biopsies were immediately cut longitudinally, with half immediately placed in liquid nitrogen and the other half frozen in standard OCT medium for IHC (immunohistochemistry). Liquid nitrogen placement was found to occur less than two minutes after the initial puncture, and OCT freezing was found to occur within five minutes of the initial puncture. Frozen punctates were maintained at -70° C. or in dry ice.

RNA was obtained using standard Qiagen® or Ambion® RNA isolation kits from punctures without allowing them to thaw. RNA was checked for quality and yield and then processed with NuGen Ovation® labeling kits for Affymetrix® U133plus2 microarray analysis. The data was transferred as files. CEL in Rosetta Resolver for analysis.

Ratios (Resolver id numbers 69671, 69672, and 69673) were calculated between the three sets of samples from the lesion (pre-dose, days 15 and 43) relative to baseline non-lesion samples, obtaining fold change values using Group 9 samples only. from patients treated with AM-14. Used chips had barcodes skn47471, skn47475, skn48862, codes

- 151 040869 skn48866, skn48870, skn48876, skn48879, skn48883

I повреждения), skn47470, skn47474, skn48861, skn48865, skn48869, skn48875, skn48878, skn48882 (из очага повреждения), skn47472, skn47476, skn48863, skn48867, skn48871, skn48877, skn48880, skn48884 (15 сутки, из очага повреждения), skn47473 , skn47477, skn48864, skn48868, skn51554, skn48881, skn51556, and skn51557 (day 43, from the lesion). The set of sequences was identified as being present in increased amounts in the skin of the lesion relative to skin not from the lesion. Some of these sequences were selected due to having high fold change values, and others were selected due to frequent mention in the literature as being associated with psoriasis immunopathology or because they are known targets for a psoriasis drug such as IL-23 and TNF.

An additional Resolver (#68458) ratio experiment for non-lesion gene expression versus lesion gene expression was performed using samples from non-study 1 psoriasis patients (purchased through Asterand®, plc., Detroit, MI) . Эти образцы включали штриховые коды микрочипов skn41609, skn41610, skn41611, skn41613, skn41614, skn41616, skn41617, skn41618, skn41619, skn41620, skn41621, skn41622, skn41623, skn41624, skn41625, skn41626, skn41698, skn41699, skn41702, skn47051, skn47052, skn47053, skn47054, skn47055, skn47056, skn47057, skn47058, skn47059, skn47060, skn47061 and skn47062.

This ratio was used to confirm that all selected probe sets reflected sequences that were up-regulated in psoriasis and could not be properly observed in the study. The ratio values in this comparison were not as high when compared between pre-dose lesion and non-damage samples from Study 1, which may be a result of different treatments used by individuals from whom extraneous samples were obtained, who may not have those same treatment restrictions.

Tab. 3.1. The psoriasis-associated sequences are highly overexpressed in lesion skin relative to non-lesion skin, and are almost completely abolished in lesion skin after treatment with AM-14. The Gene Names (Primary Sequence) are the current Entrez names for the Affymetrix® sequences, whose IDs are the sequence codes in the second column.

- 152 040869

Table 3.1

68458 69671 69672 69673 Primary Name sequences Code sequences External PsONL against PSOL Group 9 Pre NL vs group 9 Pre L multiplicity Group 9 Pre NL against groups 9D15 changes Group 9 Pre NL against group 9 D43 CXCL13 205242_at 9.3 20.9 6.6 6.5 GZMB 210164_at 3.7 7.8 2.6 1.6 IFNG 210354_at 6.3 8.5 2.5 3.0 IL12B 20790 l_at 10.0 4.3 0.8 1.0 IL17A 216876_s_at 5.0 9.3 1.8 0.8 IL17F 234408_at 3.2 3.4 0.9 ι, ο IL19 220745_at 3.6 33.9 1.1 1.2 IL1B 39402_at 6.5 24.0 1.4 0.9 IL20 22407 l_at 4.4 12.9 1.5 1.4 IL22 222974_at 3.1 10.7 1.6 ι, ο IL23A 220054_at 2.2 2.7 ι, ο ι, ο IL8 202859_x_at 3.9 58.9 1.1 0.7 KRT16 209800_at 4.4 6.5 ι, ο 1.5 KRT6A 209125_at 2.8 3.3 1.1 1.2 MMP12 204580_at 5.8 4.3 0.6 0.9 MX1 202086_at 3.6 3.5 1.9 1.5 NOS2 210037_s_at 3.2 4.6 0.9 1.3 S100A7A 232170_at 11.0 33.1 0.9 1.2 S100A8 202917_s_at 2.8 4.3 2.3 2.1 S100A9 203535_at 6.2 14.1 1.3 1.6 SERPINB13 216258_s_at 3.8 24.5 1.7 h, o SERPINB3 210413_x_at H.5 55.0 1.7 2.3 SERPINB4 211906_s_at 16.2 91.2 1.1 1.3 TNF 207113_s_at 1.5 1.5 ι, ο 0.9 Average value 5.6 18.5 1.6 1.6

PsO = psoriasis;

NL = out of damage area;

L = from the area of damage;

Pre = before dosing.

It is noteworthy that in Table. 3.1 expression of many of the genes decreases to near baseline in the undamaged area within two weeks of AM-14 treatment, in some cases reaching levels below the pre-dose level seen in non-lesional skin. It is noteworthy that TNF is reduced to the level of expression outside the lesion (fold change = 1.0), as is IL23A. IL19 is reduced only to a level of 10 to 20% above expression outside the lesion

- 153 040869 (fold change = 1.1-1.2), while IL12B actually decreases to a level below the level not in the lesion (fold change = 0.8-1.0). These changes are achieved within two weeks and are approximately maintained at these low levels for six weeks. These unprecedented changes are very rapid among the wide array of genes that are involved in the pathogenesis of psoriasis. To further subdivide changes in gene expression into functional groups of genes, the profile of RNA from cytokine-stimulated keratinocytes was determined on Affymetrix® U133 chips. Triplicate stimulation for IL-17A and for IFN-gamma were averaged in ratios (#49933 and #49939) against triplicate controls. The profiles used were barcoded skn48829, skn48833, skn48837 (control), skn48830, skn48834, skn48838, (IL-17A), and skn48832, skn48836, skn48840 (IFN-gamma).

Sequences (ie, partial sequences of the designated genes) were selected from each stimulation experiment, which may provide preferential monitoring of the effect of this cytokine. For example, the sequences selected for the IFN-gamma signature were highly statistically significant, all of which were induced at least 10-fold by IFN-gamma and not induced more than 1.2-fold (20% increase) by IL. -17A. Because IFN-gamma is such a strong stimulus, it was more difficult to select sequences for IL-17A that were not affected by IFN-gamma, but similarly, all IL-17A signature sequences were statistically significantly more highly induced than other sequences with similar expression, and were not induced significantly more by IFN-gamma. Both kits required sequences to be overexpressed in the psoriasis lesion area compared to the undamaged area. These two sets could then allow separate measurement of inflammation along each axis to analyze the effects of AM-14 treatment.

As shown in Table. 3.2, 18 sequences were selected for the IL-17 signature based on their increase in keratinocyte stimulation with IL-17A, without higher skewed expression with IFN-gamma stimulation. In both foreign samples from individuals with psoriasis and in group 9 samples, the sequences are elevated in the psoriatic lesion area of the skin. As can be seen in the last two columns, these sequences have a significant decrease in expression, returning to approximately non-lesional levels after treatment with AM-14. From an average of more than 28-fold higher expression in pre-dose biopsy specimens from the site of injury, they revert to an average of less than 2-fold within two weeks of AM-14 treatment. Some of them, including defensins S100A7 and DEF4B, have expression levels below baseline levels outside of the lesion.

Tab. 3.2. Expression of IL-17A inducible genes in keratinocytes treated with IL-17A or IFN-gamma or in skin samples from individuals with psoriasis. 18 sequences were selected as having increased levels as a result of stimulation with IL-17A for 24 h in human keratinocytes, and their fold change values were determined in relation to induction in keratinocytes after stimulation with cytokines for 24 h, in samples not from the area of damage against lesions from the lesion or from psoriatic lesion areas (with or without AM-14 treatment) compared to pre-dose non-lesion samples.

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ID experiment 49933 49939 68458 69671 20060279 Not 69672 Table 3.2 69673 Name experiment Negative control against IL-17A Negative control against IFNg Pso NL against PsOL from the lesion prior to the administration of a dose against from the lesion prior to injection 20060279 Not from 20060279 Not from fire from fire damage damage before injection before injection dose versus dose versus D15 D43 doses Primary sequence name Code sequences Multiplicity of change C15orf48 223484_at 4.7 5.5 2.5 3.8 0.6 0.8 CCL20 205476_at 4.2 0.9 5.8 28.8 1.7 1.4 CXCL1 204470_at 3.4 1.7 4.4 38.9 4.6 4.1 CXCL6 206336_at 6.0 0.5 4.2 17.8 1.5 1.2 DEFB4 207356_at 45.7 5.4 8.9 33.1 0.6 0.8 IL1F9 220322_at 5.4 2.8 4.9 22.9 1.6 2.9 LCN2 212531_at 3.7 0.5 8.5 13.8 3.8 4.2 PDZK1IP1 219630_at 10.2 11.5 2.6 6.0 1, oh 1.6 PDZK1IP1 1553589_a_at 9.8 10.7 2.6 7.1 1.1 1.4 RHCCG 219554_at 2.8 1.2 4.6 11.2 0.6 0.7 S100A12 205863_at 4.1 2.1 14.1 95.5 1.7 0.3 S100A7 205916_at 6.8 2.1 1.9 2.9 1.3 1.4 SAA1 208607_s_at 4.3 3.7 1.6 3.7 3.5 4.9 SAA1 214456_x_at 2.9 2.8 2.0 3.6 4.0 3.7 SPRR2C 220664_at 5.9 0.9 10.5 32.4 0.5 0.5 TMPRSS11D 207602_at 7.8 6.3 4.1 89.1 2.3 0.8 VNN3 220528_at 83.2 11.0 8.9 100.0 2.9 1.7 ZC3H12A 218810_at 3.2 1.8 3.0 4.7 1.7 1.4 Average value 11.9 4.0 5.3 28.6 1.9 1.9

As shown in Table. 3.3, thirty-three sequences were selected for the IFNgamma signature based on their increased levels when stimulated with IFNgamma in keratinocytes, without higher expression when stimulated with IL-17A. Both in foreign samples from individuals with psoriasis and in samples from study 1, the content of sequences in the skin of the area of damage is increased. As can be seen in the last two columns, these sequences have a significant but not complete decrease in expression, reverting to non-damaged levels after AM-14 treatment. Some of them, such as CCL2 and IRF1, have expression levels consistent with non-lesional expression levels or lower levels for two weeks after AM-14 treatment, while others, such as CCL7 and TNFRSF9, continue to decline over time.

Table 3.3. Expression of IFN-inducible genes in keratinocytes stimulated with IL-17A or IFN-gamma, or in skin samples from individuals with psoriasis. Thirty-three sequences were selected as having increased levels upon stimulation with IL-17A for 24 h in human keratinocytes, and their fold change values were determined in relation to induction in keratinocytes after stimulation with cytokines for 24 h, in samples not from lesion versus lesions from the lesion or from psoriatic lesions (with or without AM-14 treatment) compared to pre-dose non-lesion samples.

Table 3.3

ID 49933.0 49939.0 68458.0 69671.0 69672.0 69673.0 experiment 20060279 Not from the hearth 20060279 Not 20060279 Not Negative- Negative- damage from the hearth from the hearth body body PsO NL before the introduction Name control control against doses vs. damage damage experiment against against PSOL from the hearth before the introduction before the introduction IL-17A IFNg doses vs. doses vs. damage D15 D43 before the introduction doses Primary Code Name follow- Multiplicity of change follow- validity validity 1570541_s_at 157054 l_s_at 1.0 100.0 5.5 6.5 2.1 1.9 239979_at 239979_at 0.8 17.0 4.2 3.3 2.4 2.2 ACE2 219962_at 1.0 31.6 4.9 8.5 1.5 1.6 AIM2 206513_at 0.8 100.0 5.5 4.3 1.9 1.7 APOL1 209546_s_at 0.9 63.1 2.7 2.6 1.3 1.1 APOL6 219716_at 0.9 17.8 3.3 2.7 1.1 0.8 APOL6 241869_at 0.7 41.7 4.1 1.9 1.1 1.0 CCL22 20786 l_at 0.9 22.4 3.5 3.5 0.9 1.2 CCL5 1405_i_at 0.2 22.4 1.5 1.4 2.2 2.1 CCL5 204655_at 0.3 20.0 1.4 1.3 2.3 1.8 CCL7 208075_s_at 0.5 89.1 3.8 5.4 1.6 1.0 CCL8 214038_at 0.8 100.0 1.7 1.8 1.3 1.0 CLEC7A 221698_s_at 0.9 21.4 2.8 3.6 1.9 1.7 EB 13 219424_at 0.4 21.4 3.6 3.1 1.3 1.1 GBP4 235175_at Ι,ο 100.0 1.8 1.2 1.3 1.1 GBP5 238581_at 0.8 100.0 6.6 4.6 3.1 2.1 GBP5 229625_at 0.8 91.2 3.0 3.3 2.6 2.2 IFIT3 204747_at 0.9 21.4 2.9 3.0 1.1 1.3 IL12RB1 1552584_at 0.6 61.7 2.0 2.3 1.7 1.6 IL2RG 204116_at 0.6 67.6 2.0 2.0 1.3 1.5 IL32 203828_s_at 0.5 19.5 2.1 1.4 1.5 1.8 IRF1 238725_at 0.8 83.2 1.9 1.3 1.0 0.9 ISG20 33304_at 1.0 53.7 3.2 3.2 1.3 1.3 ISG20 204698_at 1.2 45.7 2.9 2.8 1.3 1.1 LIPA 236156_at 0.7 27.5 2.9 2.3 1.4 1.0 RSAD2 213797_at 1.1 46.8 6.0 9.8 2.5 1.6 RSAD2 242625_at 1.1 52.5 4.5 3.9 1.3 1.1 RTP4 219684_at 0.6 100.0 4.3 6.0 3.2 1.9 SAMD9L 226603_at 0.8 19.1 1.7 1.5 1.4 1.3 SLC15A3 219593_at 1.0 100.0 1.3 1.0 1.0 1.0

- 156 040869

TNFRSF9 211786 a! 0.6 14.1 3.1 3.3 2.1 1.5 TRIM10 221627_at 0.7 21.4 4.2 13.8 3.6 3.6 XAF1 20613 For! 0.9 16.6 2.3 1.8 1.6 1.2 Average 0.8 51.7 3.1 3.4 1.7 1.5

meaning

The IL-17A and IFN-gamma response gene sets were further reduced by deleting two sequences that had extremely high correlation coefficients with another sequence from the same gene. Probe sets 208607_s_at (SAA1) and 219630_at (PDZK1IP1) were excluded from the IL-17A signature shown in Table 1. 3.2, and probe sets 1405_i_at (CCL5) and 213797_at (RSAD2) were excluded from the IFN-gamma signature shown in Table 3.2. 3.3. The remaining sequences were used to calculate the Mahalanobis distance from a central set of skin profiles from healthy individuals for each set of sequences (Table 3.4). In this calculation, a set of original normal skin samples is used to determine the mean for each sequence and a sequence set covariance matrix, which is used in combination with the normalized intensities for the sequences for each sample to determine the Mahalanobis distance score for that sample for that set of genes. Distances were also calculated for non-lesional and non-damaged foreign samples and are in a similar range to pre-dose samples from Study 1. Not surprisingly for these two sets of inflammatory cytokine-regulated genes, skin lesion samples have significantly more higher signature distances than samples not from the damaged region. This is true for both the off-set and pre-dose samples in this study. Surprisingly, the long pre-dose signature distances were significantly reduced after a single dose of AM-14, with the IFN-gamma signature distance decreasing mostly in the direction of the intact area value, and the IL-17A signature distance decreasing even below the intact area value.

Table 3.4

Mahalanobis Average Distance

Distance for IFN- Distance for IL17A Out of the damage area before gamma 674 10403 dose administration From the damaged area to 8465 627631 dose administration Out of damage area for 15 2338 4133 day From the area of damage on 43 1705 1329 day Out of the area of damage 712 82285 outsider From the area of damage 11122 649648 outsider

Taken together, these data demonstrate a significant molecular change (i.e., downregulation of genes that are involved in the pathogenesis of psoriasis) in the skin from the area of psoriasis injury as a result of AM-14 treatment, which occurs rapidly and is maintained or increased up to six weeks after dosing. This change is observed for a wide range of genes that are involved in inflammation and are thought to be involved in psoriasis. It is also observed for a number of genes that are activated by IFN-gamma in keratinocytes and is most striking for a set of genes that are activated by IL-17A. This genotypic response correlates with the percentage reduction in PASI scores presented in Example 2 for patients treated with AM-14. The rapidity of morphological and genotypic responses in psoriasis patients treated with AM-14 is unprecedented and may be unique for AM-14 (and other anti-IL-17RA antibodies described herein) as well as for IL-17RA antagonists, such as defined herein, such as antibodies that bind IL-17A and block its binding to IL-17RA and/or IL-17RC and/or

- 157 040869 heteromeric receptors containing IL-17RA and IL-17RC.

Example 4 Histological Analysis of Psoriasis Patients Treated with Anti-IL-17 A Receptor Monoclonal Antibody.

The experiments presented below demonstrate that inhibition of IL-17R activation strongly influences histopathological responses in patients with psoriasis. Administration of AM-14 (700 mg IV, single dose) to individuals with psoriasis resulted in significant improvements in a variety of histopathological parameters compared to placebo. These parameters include epidermal thickness, Ki-67 and keratin 16 levels. These data are presented in FIG. 14-16. In FIG. 14 shows changes in epidermal thickness over time in individuals treated with AM-14 (filled symbols). AM-14 administration resulted in significant reductions in epidermal thickness in individuals with psoriasis compared to placebo (open circles). In FIG. 15 shows changes in keratin-16 (KRT16) levels over time in AM-14 treated individuals (solid symbols) compared to placebo (open circles). The introduction of AM-14 resulted in a significant decrease in the amount of mRNA KRT16 in individuals with psoriasis compared with placebo. In FIG. 16 shows changes in the amount of Ki67 over time in AM-14 treated individuals (solid symbols) compared to placebo (open circles). AM-14 resulted in a significant reduction in Ki67 in individuals with psoriasis compared to placebo.

In addition, administration of AM-14, as described in the previous paragraph, reduced the number of infiltrating skin leukocyte subsets (CD3 ⁺ , CD11c ⁺ , CD8 ⁺ , DC-LAMP+), as shown in Table 1. 4.0. The decrease in leukocyte subgroup levels indicates that both T cell levels (CD3+ and CD8+) and mature dendritic cells (CD11c ⁺ and DC-LAMP+) were reduced with AM-14 treatment. Both of these subgroups of cells are involved in the amplification and maintenance of pro-inflammatory conditions in psoriatic skin.

Histopathological findings correlated with significant improvements in PASI as 7 of 8 individuals achieved at least a 75% improvement in PASI score at week 6. Together, these data point to multiple histological implications of IL-17 activation and subsequent inhibition in human skin by AM-14.

- 158 040869

Table 4.0

CD3+

Individual NL LS d0 LS dl4 LS d42 AM-14 A 92 305 258 149 AM-14 V 171 139 144 83 RVO A 8 155 508 247 AM-14 C 27 368 253 105 AM-14D 50 507 0 176 RVOV 37 295 338 374 AM-14 E ΝΑ 600 284 201 AM-14F 57 143 153 168 AM-14G 54 248 244 88 AM-14 N 46 177 102 54 Average value 71 311 180 128 sd 48 171 98 53

CDllc+

Individual NL LS dO LS dl4 LS d42 AM-14A 189 478 336 168 AM-14V 57 205 124 167 PBO A thirty 141 264 298 AM-14C 85 322 696 85 AM-14D 72 463 235 228 RVOV 77 192 488 985 AM-14E 358 156 156 AM-14F 108 987 318 150 AM-14G 42 128 93 78 AM-14H 79 204 285 109 Average value 90 393 280 143

- 159040869

sd 48 271 191 50

CD8+

Individual NL LS d0 LS dl4 LS d42 AM-14 A AM-14 V 35 103 61 19 RVO A eleven 64 92 43 AM-14 C 56 56 150 39 AM-14D 26 118 165 89 RVOV 7 thirty 60 172 AM-14 E 231 67 46 AM-14F 6 284 55 106 AM-14G 47 28 64 48 AM-14 N 72 132 63 48 Average value 40 136 89 56 sd 23 92 47 thirty

DC-LAMP

Individual NL LS dO LSdl4 LS d42 AM-14A AM-14 V 10 48 19 eleven PBO A 0 92 60 59 AM-14C 5 67 148 8 AM-14D 0 32 15 45 RVOV 0 98 142 250 AM-14E 267 5 2 AM-14F 0 150 28 14 AM-14G 0 42 6 4 AM-14H 0 56 3 0 Average value 3 95 32 12 sd 4 86 52 15

EXAMPLE 5 Burning study after administration of a glutamate formulation.

Six formulation buffers were tested in a total of 72 healthy human participants for three days. None of the buffers contained antibody. Participants rated and recorded pain/burning after injection of each buffer using a 100 mm visual analogue scale, where higher numbers correspond to more pain (referred to as VAS). After all injections, participants ranked the buffers in terms of perceived pain/burning from least painful to most painful (buffers 1-6).

The following six buffers were evaluated:

A: 10 mM sodium acetate, pH 5.2, 9% sucrose, 0.004% polysorbate 20;

B: 10 mM monosodium glutamate, pH 4.8, 9% sucrose, 0.01% polysorbate 20;

C: 30 mM monosodium glutamate, pH 4.8, 8% sucrose, 0.01% polysorbate 20;

D: 10 mM sodium acetate, pH 4.8, 3% L-proline, 0.01% polysorbate 20;

E: 30 mM monosodium glutamate, pH 4.8, 3% L-proline, 0.01% polysorbate 20;

F: 20 mM sodium citrate, pH 5.0, 5% sorbitol.

Buffer A was the formulation buffer AM-14 used in the clinical trials described in Examples 2-4 and 6 and was designated as Comparative Buffer. Buffer F was a citrate-based buffer and was considered a positive control buffer for relative pain/burning due to its reputation in the art for burning when injected subcutaneously.

- 160040869

The results of the study demonstrate that:

(a) Subcutaneous injection of positive control buffer (F) resulted in palpable transient localized pain (burning) at the injection site (mean VAS=56.9 mm (SD=±30.64), median VAS=59.5 mm) ;

(b) subcutaneous injection of other buffers (A-E) resulted in significantly less reported burning (mean VAS values ranging from 12.1 to 28.4 mm, mean VAS values from 4.5 to 15.0 mm, p<0 .0001);

(c) based on average VAS scores, the order (from least to worst) of reported burning for buffers was B<A<D<E<C<F;

(d) based on the median VAS scores, the order (from least to worst) of reported burning for the buffers was B<A<D<C<E<F;

(e) after all injections, participants ranked buffers (1-6) by perceived burning sensation from least painful to most painful. Median rankings of burning participants were buffers A=B=D<buffer C=E<buffer F;

(f) Pairwise comparisons of VAS scores showed that the burning sensation induced by comparative buffer A and buffers B and D was indistinguishable (p=0.47 and 0.07, respectively), but the burning sensation induced by buffer B was less than that for buffer D (p=0.01), and that buffers containing 30 mM glutamate (buffer C and E) caused somewhat more burning than buffer containing 10 mM glutamate (buffer B, p<0.0005). Pairwise comparisons are presented in Table. 5.0.

These data demonstrate the surprising result that the 10 mM glutamate formulation does not induce an unacceptable degree of burning in humans when injected subcutaneously.

Table 5.0 ______Carrier Pairwise Comparison Summary of Pain Scores_____

Comparable treatments Difference Confidence interval Upper lower p value A vs. F -42.3 90 -48.0 -36.6 <0.0001 B vs. F -44.8 95 -51.6 -38.0 <0.0001 C vs. F -28.4 95 -35.3 -21.6 <0.0001 D vs. F -36.0 95 -42.8 -29.2 <0.0001 E vs. F -32.6 95 -39.5 -25.8 <0.0001 A versus B 2.5 90 -3.2 8.2 0.4700 A vs. D -6.3 90 -12.0 -0.6 0.0711 B vs. D -8.8 95 -15.6 -2.0 0.0117 B vs C -16.4 95 -23.2 -9.5 <0.0001 B vs. E -12.2 95 -19.0 -5.3 0.0005

Example 6 Phase 2 trial of AM-14 in psoriasis.

A phase 2, randomized, double-blind, placebo-controlled, multiple-dose, phase 2 trial to evaluate the safety, tolerability, and efficacy of AM-14 in individuals with moderate to severe plaque psoriasis was conducted to establish the dose-response profile of AM-14 versus placebo as measured by percentage. improvement from baseline in psoriasis coverage and severity score (PASI) at week 12 and to identify an appropriate dosing regimen for subsequent trials. For more information see ClinicalTrials.gov Identifier no. NCT00975637.

Inclusion Criteria.

The subject had stable moderate to severe plaque psoriasis for at least 6 months.

The subject has received at least one previous phototherapy or systemic therapy for psoriasis or is a candidate for phototherapy or systemic therapy for psoriasis in the judgment of the investigator.

The individual has an involved BSA >10% and PASI >12 at screening and at baseline.

exclusion criteria.

The subject is diagnosed with erythrodermal psoriasis, pustular psoriasis, drug-induced or drug-aggravated psoriasis.

- 161 040869

Evidence of skin conditions at the screening visit (eg, eczema, guttate psoriasis) that would preclude assessment of the effect of IP on psoriasis.

The individual has any active category 2 or higher STCAE infection.

The subject has a significant comorbid medical condition or laboratory abnormality as defined in the study protocol.

The subject used the following treatments within 14 days of the first dose: UVB therapy or topical psoriasis therapy other than topical class I or II steroids.

The subject used the following treatments within 28 days of the first dose: class I or II topical steroids, UVA therapy (with or without psoralen), or systemic therapy for psoriasis.

The subject has used the following therapy within 3 months of the first dose: adalimumab, alefacept, etanercept, infliximab, certolizumab, or live vaccines.

The subject used an IL12/IL23 inhibitor within 6 of the first dose.

The subject has previously used an anti-IL17 biological therapy, efalizumab or rituximab.

The study evaluated the efficacy of AM-14 versus placebo as measured by percentage improvement in PASI score at week 12. After signing informed consent forms, completing all screening evaluations, and meeting all inclusion criteria, approximately 175 individuals were randomized into groups in a 1:1:1:1:1 ratio and treated with AM-14 and/or placebo for 1 day and 1 week , 2, 4, 6, 8, and 10. Individuals were randomly assigned to receive AM-14 administered at 70, 140, or 210 mg on day 1 and at weeks 1, 2, 4, 6, 8, and 10 or 280 mg on Day 1 and Weeks 4 and 8. For approximately 50 individuals, additional samples at additional time points for PK analysis were collected for the substudy. Approximately 175 individuals in the main study were assessed for PK with sparse sampling. Randomization was stratified to ensure treatment balance in the PK substudy and on body mass index (above and below 35). Skin samples were taken from approximately 32 individuals in a subgroup of study areas at day 1 (1 each, from the injury site and not from the injury site), at week 2 (from the injury site only), and at week 12 (from the injury site only). ). Serum, plasma and blood RNA were obtained from all individuals.

AM-14 was provided as a sterile, preservative-free liquid containing 70 mg/ml AM-14 formulated with 10 mM sodium acetate, 9% sucrose, 0.004 w/v% polysorbate 20 at pH 5.2. The formulation was provided as a frozen liquid in glass vials containing a 1 ml delivery volume (single use only). Clinical provision of placebo was carried out in glass vials as a frozen sterile protein-free solution. The vials were disposable vials containing approximately 1 ml of carrier solution per vial. The control group received placebo at day 1 and at weeks 1, 2, 4, 6, 8 and 10 (Q2WK + week 1). Other individuals received one or more injections of placebo as needed to maintain the blinded nature of the study.

The PASI score was blinded by the rater. The blind assessor was a healthcare professional certified as trained using standard PASI training materials provided by Amgen. To maintain a blinded nature of the study, the rater did not have any other interaction with individuals other than the PASI, sPGA, and BSA involvement scores. The evaluator did not discuss the individual's clinical status and did not have access to the individual's medical records or CRF, including prior evaluation data. The PASI was assessed by the same assessor throughout the study.

PASI 75, 90, and 100 responses at week 12 are shown in Table 1. 6.0. This study demonstrates that AM-14 is effective for the treatment of psoriasis (particularly moderate to severe plaque psoriasis) at doses ranging from 70 to about 300 mg and specifically at doses of 70, 140, 210 and 280 mg at dosing regimens described above. These data demonstrate that AM-14 was effective relative to placebo at all doses tested (70, 140, 210 and 280 mg).

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Claims (8)

Table 6.0 PASI Responses 75, 90, 100 at Week 12 placebo (N=38) n/Nl (%) AM-14 70 mg q2W (N=39) n/Nl (%) AM-14 140 mg q2W (N=39) n/Nl (%) AM-14 210 mg q2W (N=40) n/Nl (%) AM-14 280 mg q4W (N=42) n/Nl (%) PASI 75 response, P value 0/38 (0.0%) 13/39 (33.3%) <0.0001 30/39 (76.9%) <0.0001 33/40 (82.5%) <0.0001 28/42 (66.7%) <0.0001 PASI 90 response, P value 0/38 (0.0%) 7/39 (17.9%) 0.0057 28/39 (71.8%) <0.0001 30/40 (75.0%) <0.0001 24/42 (57.1%) <0.0001 PASI 100 response, P value 0/38 (0.0%) 4/39 (10.3%) 0.0452 15/39 (38.5%) <0.0001 25/40 (62.5%) <0.0001 12/42 (28.6%) 0.0003 N = number of randomized participants. N = number of respondents. N1 = number of participants who were randomized and had a significant value when measured at week 12, after evaluation %=n/N1x100. The P value is provided for comparison between each AM-14 and placebo dose group and is nominal without multiplicity adjustment. The P value was based on the Cochran-Mantel-Hensel test, stratified by the BMI group (<35, >35) and adjusted for the PASI baseline group (<median (17.45), >median (17, 49)) NRI (score of non-responders) was used to evaluate missing data. CLAIM 1. Pharmaceutical composition for the treatment of an inflammatory disease, containing an aqueous solution of a buffer based on glutamic acid and an antibody containing a heavy chain CDR1 containing SEQ ID NO: 5, a heavy chain CDR2 containing SEQ ID NO: 7, a heavy chain CDR3 containing SEQ ID NO: 8, a light chain CDR1 containing SEQ ID NO: 9, a light chain CDR2 containing SEQ ID NO: 10, and a light chain CDR3 containing SEQ ID NO: 11, where: (i) said antibody specifically binds human IL-17 receptor A; (i i) the inflammatory disease is psoriasis, psoriatic arthritis, asthma, ankylosing spondylitis, or multiple sclerosis; (i ii) said formulation contains: a) glutamic acid at a concentration of 30±0.2 mM; b) pH 4.5-5.2±0.2; c) 2-4% w/v proline and 0.01±0.002% w/v polysorbate 20; d) antibody at a concentration of about 140 to 250 mg/ml. 2. The pharmaceutical composition of claim 1, wherein the antibody comprises a heavy chain variable domain sequence comprising SEQ ID NO: 3 and a light chain variable domain sequence comprising SEQ ID NO: 4. 3. The pharmaceutical composition of claim 1, wherein the antibody comprises a heavy chain sequence comprising SEQ ID NO: 1 and a light chain sequence comprising SEQ ID NO: 2, or alternatively a heavy chain sequence comprising SEQ ID NO: 12 and a light chain sequence containing SEQ ID NO: 2. 4. Pharmaceutical composition according to any one of claims 1 to 3, additionally having an osmolarity of 275-325 Osm. 5. Pharmaceutical composition according to any one of claims 1 to 4, which contains the antibody at a concentration of approximately 140 mg/ml. 6. Pharmaceutical composition according to any one of claims 1 to 4, which contains the antibody at a concentration of approximately 210 mg/ml. 7. Pharmaceutical composition according to any one of claims 1 to 4, which contains the antibody at a concentration of approximately 250 mg/ml. 8. A pharmaceutical container containing a container and a pharmaceutical composition according to any one of claims 1 to 7, where the container is a vial, bottle, pre-filled syringe or pre- - 163 -