A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized Double-Blind Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants with Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous

Brief description of study

The overall objective of this study is to evaluate the efficacy and safety of BIIB059 compared to placebo in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials.
The study duration for each participant will be approximately 80 weeks with a Screening period of up to 30 days, a double-blind placebo-controlled period of 24 weeks, an extended treatment period of 28 weeks, and an safety follow-up period of 24 weeks.


Clinical Study Identifier: s20-01130
ClinicalTrials.gov Identifier: NCT05531565
Principal Investigator: David H. Goddard.


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