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)
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- STATUS
- Recruiting
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- End date
- Dec 13, 2026
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- participants needed
- 474
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- sponsor
- Biogen
Summary
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].
Description
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.
Details
| Condition | Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus |
|---|---|
| Treatment | Placebo, BIIB059, BIIB059 (litifilimab) |
| Clinical Study Identifier | NCT05531565 |
| Sponsor | Biogen |
| Last Modified on | 13 August 2023 |
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