A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)

  • End date
    Dec 13, 2026
  • participants needed
  • sponsor
Updated on 13 August 2023


The primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab) compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B].


BIIB059 is a humanized immunoglobulin G1 (IgG1) monoclonal antibody targeting blood dendritic cell antigen 2 and is being investigated for the potential treatment of systemic lupus erythematosus and cutaneous lupus erythematosus.

Condition Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
Treatment Placebo, BIIB059, BIIB059 (litifilimab)
Clinical Study IdentifierNCT05531565
Last Modified on13 August 2023


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Any active skin conditions other than CLE that may interfere with the study assessments of CLE
Active severe lupus nephritis
Active neuropsychiatric SLE
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 randomization, have not been at a stable and allowable dose
Use of intralesional corticosteroids within 1 week prior to Screening and during the study
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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