Overview
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.
Eligibility
Key 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.
Key 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 intralesional corticosteroids within 1 week prior to Screening and during the study.
- 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.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply