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A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects With Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects With Active Cutaneous Lupus Erythematosus With or Without Systemic Manifestations

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Trial Profile

A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects With Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects With Active Cutaneous Lupus Erythematosus With or Without Systemic Manifestations

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 08 Sep 2026

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At a glance

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

Most Recent Events

  • 28 Mar 2026 According to a Biogen media release, data from this trial is being presented today at the American Academy of Dermatology (AAD) Annual Meeting.
  • 28 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.
  • 28 Jan 2026 According to a Biogen media release, the USFDA has granted Breakthrough Therapy Designation for litifilimab (BIIB059) for the treatment of CLE, based on the totality of litifilimab data, including the results from the Phase 2 LILAC study.

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