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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: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 16 Feb 2025

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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

    • 02 Sep 2022 Planned End Date changed from 18 Oct 2026 to 13 Dec 2026.
    • 03 Aug 2022 New trial record
    • 28 Jul 2022 According to a Biogen media release, the company plans to initiate the trial in late 2022.

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