A Study to Evaluate Litifilimab in Adults with Active Subacute or Chronic Cutaneous Lupus Erythematosus
Official Title
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)
Purpose
The purpose of this study is to evaluate the efficacy of BIIB059 (Litifilimab)
Could this study be right for you?
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Subject must have a diagnosis of cutaneous lupus erythematosus with active skin lesions
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Subject must have tried an antimalarial treatment (i.e., hydroxychloroquine, quinacrine, or chloroquine) for at least 12 weeks (about 3 months) or was unable to tolerate antimalarial treatment due to side effects
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Subject must be in good general health with no history of tuberculosis, heart failure, cancer, HIV, or hepatitis B or C
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Female subjects must not be pregnant, breastfeeding, or considering becoming pregnant for the duration of the study