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Site for 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 Lupus Erythematosus with or without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)
SLE/CLE Lupus: 18 years and older; SC (subcutaneous injection) every 4 weeks with an additional dose given at Week 2 and Week 26. Randomization is 2:1 BIIB059 to placebo (non active ingredient); 52 weeks of treatment. There are 2 parts to the study, Part A and Part B. The goal of Part A is to confirm the adequacy of an investigator specific evaluation. The goal of Part B is to demonstrate the efficacy and safety of BIIB059 compared with placebo.
You will attend 21 visits and have 2 phone calls over approximately 52 weeks. At different time points throughout the study you will have photographs taken of your lesions, labs drawn, an ECG performed, skin examinations, a chest x-ray, you will need to complete questions, and fill out a diary.
Previous use and failure of antimalarial agents; study coordinator will discuss further
Certain medications not allowed; study coordinator will discuss
Certain medical history may be excluded from participation; study coordinator will discuss