Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability of CJM112 in Psor… (NCT01828086) | Clinical Trial Compass
CompletedPhase 1
Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability of CJM112 in Psoriasis
United States95 participantsStarted 2013-06
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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
What they're measuring
1
Number of participants with adverse events as a measure of safety