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: Lupus, Systemic Lupus Erythematosus
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.
Locations
UH Cleveland Medical Center
11100 Euclid Ave
Cleveland OH, 44106
- UH IRB: SITE00001693
- StudyID: 2022-0872
- ClinicalTrials.gov: NCT05531565
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