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Clinical trial

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)

NCT05531565 is registered in ClinicalTrials.gov with Biogen as lead sponsor.

NCT NCT05531565
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Registry record

As filed in ClinicalTrials.gov.

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)
Lead sponsor
Biogen
Phase
Phase 2/3
Overall status
Active, not recruiting
Start date
September 13, 2022
Completion date
December 14, 2027
Enrollment
450 (estimated)
Sites
315

Conditions

As the registry lists them; a condition with its own page is linked.

chronic cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus