Alopecia Areata Clinical Trial
Official title:
A Phase 2, Randomized, Double-blind, Placebo--controlled, Parallel Group, 3-arm, Multinational, Multicenter, Proof-of-concept Study to Evaluate the Efficacy and Safety of Amlitelimab Monotherapy by Subcutaneous Injection in Adult Participants With Severe Alopecia Areata
This is a parallel, Phase 2 multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study to investigate the efficacy and safety of subcutaneous (SC) injections of amlitelimab treatment as monotherapy in participants aged 18 years and older with severe alopecia areata (AA). At the end of the treatment period, all participants will have the option to enter a separate study, the open-label extension (OLE) study, once eligibility is confirmed. The study duration will be up to 56 weeks for participants not entering the OLE including a 2-to-4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the OLE, the DRI18180 study duration will be up to 40 weeks, including a 2-to-4-week screening, a 36-week randomized double-blind period The total number of visits will be up to 12 visits (or 11 visits for those entering the OLE study).
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|---|---|---|---|
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