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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: 22 Feb 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 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.
  • 28 Jan 2026 According to Lupus Research Alliance media release, company applauds the decision by the U.S. Food and Drug Administration (FDA) to grant Breakthrough Therapy designation for litifilimab (BIIB059) in clinical development by Biogen Inc. for the treatment of cutaneous lupus erythematosus.The FDA grants this designation to expedite the review of drugs that may demonstrate substantial improvement over available therapies.
  • 15 Nov 2023 Results assessing effects of litifilimab on IFN gene signature scores from whole blood samples, serum IFNalpha concentrations, and other serum cytokine concentrations in participants from this trial presented at the ACR Convergence 2023

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