A Randomized, Double-blind, Placebo and Positive Controlled, Single and Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CJM112 in Chronic Plaque-type Psoriasis Patients

Date de début de l'étude : 1 juin 2013

Inclusion Criteria: Men or women 18-65 years of age at time of consent Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization At randomization, moderate to severe psoriasis as defined by: PASI score of 12 or greater and, IGA score of 3 or greater and, Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater. Female patients may be included according to the following: Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, using highly effective methods of contraception during dosing and for 5 times the terminal half-life of study treatment. • Male subjects must agree to comply with two highly effective contraceptive methods Exclusion Criteria: Forms of psoriasis other than chronic plaque-type (incl. drug induced psoriasis) Ongoing use of prohibited psoriasis treatments and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to Previous treatment with IL-17 or IL17R blocking agents, including secukinumab Any live vaccines (including nasal-spray flu vaccine) starting from 6 weeks before screening, during the study, and up to 24 weeks after the last dose of CJM112 or secukinumab Evidence of active tuberculosis at screening Active systemic infections (other than common cold) Pregnant or nursing (lactating) women