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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with adverse events as a measure of safety