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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)

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Trial Profile

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)

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 06 Sep 2026

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At a glance

  • Drugs Litifilimab (Primary)
  • Indications Cutaneous lupus erythematosus; Discoid lupus erythematosus
  • Focus Registrational; Therapeutic Use
  • Acronyms AMETHYST
  • Sponsors Biogen

Most Recent Events

  • 16 Jun 2026 Status changed from recruiting to active, no longer recruiting.
  • 11 Jun 2026 This trial has been completed in Slovakia, Sweden, and Italy.
  • 29 Mar 2026 According to a Biogen media release, Phase 2 results from LILAC and AMETHYST supported litifilimabs recently granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation.

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