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Evaluating the effects of litifilimab injections on skin symptoms in adults with cutaneous lupus erythematosus

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)

Phase2; Phase3 Interventional Biogen · NCT05531565

This study is testing if litifilimab injections can help adults with skin symptoms from cutaneous lupus erythematosus who haven't found relief with other treatments.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment450 (estimated)
Ages18 Years and up
SexAll
SponsorBiogen Industry-sponsored
Drugs / interventionslitifilimab
Locations314 sites (Anniston, Alabama and 313 other locations)
Trial IDNCT05531565 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy of litifilimab (BIIB059), a monoclonal antibody, in reducing symptoms of active cutaneous lupus erythematosus (CLE) in adult participants. It focuses on individuals with subacute or chronic CLE who have not responded to antimalarial treatments. Researchers will assess the drug's impact on skin disease activity using various scoring tools, including the CLA-IGA-R and CLASI-A scores. The study consists of two parts, with participants receiving either litifilimab or a placebo to compare outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults with active cutaneous lupus erythematosus who have not responded to antimalarial therapy.

Not a fit: Patients with other active skin conditions or overlapping autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve skin symptoms and quality of life for patients suffering from cutaneous lupus erythematosus.

How similar studies have performed: Other studies have shown promise with similar monoclonal antibody approaches in treating lupus, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Histologically confirmed (in the past or during the Screening period) diagnosis of CLE with or without systemic manifestations.
2. Must have active cutaneous manifestations that meet study criteria.
3. Must have a CLASI-A score ≥10.
4. Must have an active CLE lesion despite an adequate trial of antimalarial treatment.

Key Exclusion Criteria:

1. Any active skin conditions other than CLE that may interfere with the study assessments of CLE.
2. Diagnosis of mixed connective tissue disease \[(within 1 year of signing the informed consent form (ICF)\] or any history of overlap syndromes of SLE including concomitant presence with rheumatoid arthritis, dermatomyositis and/or polymyositis, systemic sclerosis, psoriatic arthritis, or any other autoimmune disease that may confound the evaluation of the disease activity or the effect of the investigational product. Exceptions for overlap syndrome of SLE include participants with overlap syndrome of SLE with myositis and secondary Sjögren's syndrome at screening is permitted provided the participant also meets the criteria for classification as SLE. A past history of mixed connective tissue disease that over time has developed into a diagnosis of SLE is permitted, provided diagnosis of SLE has been present for at least 1 year.
3. Active severe lupus nephritis.
4. Active neuropsychiatric SLE.
5. Use of intralesional corticosteroids within 1 week prior to Screening and during the study.
6. Use of immunosuppressive or disease-modifying treatments for SLE or CLE \[via an oral, intravenous (IV), or SC route\] that were initiated less than 12 weeks prior to screening, have not been at a stable and allowable dose.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply

Where this trial is running

Anniston, Alabama and 313 other locations

+264 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Subacute Cutaneous Lupus ErythematosusChronic Cutaneous Lupus ErythematosusCutaneous Lupus ErythematosusDiscoid Lupus ErythematosusSystemic Lupus ErythematosusLupus
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.