Psoriasis Clinical Trial
Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability of CJM112 in Psoriasis
Summary
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. This trial never made it to the Phase II part of this trial.
Eligibility Criteria
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
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There are 18 Locations for this study
Anniston Alabama, 36207, United States
Anaheim California, 92801, United States
Encino California, 91436, United States
North Hollywood California, 91606, United States
Miami Florida, 33136, United States
Miami Florida, 33175, United States
Orlando Florida, 32809, United States
Tampa Florida, 33609, United States
Normal Illinois, 61761, United States
Indianapolis Indiana, 46256, United States
Overland Park Kansas, 66211, United States
Crowley Louisiana, 70526, United States
Raleigh North Carolina, 27612, United States
Cincinnati Ohio, 45255, United States
Oklahoma City Oklahoma, 73112, United States
Philadelphia Pennsylvania, 19103, United States
Austin Texas, 78759, United States
San Antonio Texas, 78229, United States
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