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- AMETHYST: 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
Clinical Trial
AMETHYST: 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
The overall objective of this study is to evaluate the efficacy and safety of BIIB059 (litifilimab) compared to placebo in participants with active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) with or without systemic manifestations and refractory and/or intolerant to antimalarial drugs. The specific objectives of the study are diffeent for each part of the study.
- Integumentary System
- Antimalarial Treatment
- Chronic Cutaneous Lupus Erythematosus (CCLE)
- Litifilimab
- Subacute Cutaneous Lupus Erythematosus (SCLE)
Eligibility Criteria
- INCLUSION: 1. Adults age 18 or older with confirmed cutaneous lupus erythematosus (CLE) based on protocol-defined criteria. 2. Have active CLE despite being on an adequate trial of antimalarial treatment, as defined by the protocol. EXCLUSION: 1. No current or past history of protocol-prohibited medical conditions or medications 2. No lab values outside of parameters defined in the protocol
RESEARCH. INNOVATION. DISCOVERY.