AMETHYST – Lupus Study
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)
- Sex: Any
- Age: Adult (18 - 64), Older Adult (65+)
- Accepting Healthy People: No
- Type: Interventional / Therapeutic
- Trial Phase: Phase II/III
- Conditions Being Studied:
Study Purpose
The purpose of this study is to evaluate if the investigational study drug, BIIB059, can reduce disease activity and inflammation in people with active CLE compared to a placebo.
Who Can Participate
Participants 18 years and older who has been diagnosed with an autoimmune disease known as cutaneous lupus erythematosus may be eligible for this study.
- UH IRB: SITE00001693
- StudyID: 2022-0872
- ClinicalTrials.gov: NCT05531565
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