A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus
Status and phase
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Study type
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Identifiers
Details and patient eligibility
About
The purpose of this study is to assess the safety and drug levels of BMS-986256 in participants with cutaneous lupus erythematosus.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
a) Must have one of following diagnoses: i) Meet European League Against Rheumatoid (EULAR)/American College of Rheumatology 2019 Classification Criteria for systemic lupus erythematosus (SLE) OR ii) Biopsy-proven acute cutaneous lupus erythematosus (ACLE), subacute cutaneous lupus erythematosus (SCLE), or discoid lupus erythematosus (DLE): Participants without a concurrent SLE diagnosis are eligible b) Active cutaneous lupus disease, defined as a modified Cutaneous Lupus Erythematosus Disease Area and Severity Index- Activity (mCLASI-A) score ≥ 6 c) Active cutaneous lupus skin lesion(s) amenable to biopsy
• Women of childbearing potential (WOCBP) and men must agree to follow instructions for method(s) of contraception, if applicable
Exclusion criteria
- Active severe or unstable neuropsychiatric SLE
- Active, severe Lupus Nephritis (LN)
- Any British Isles Lupus Assessment Group (BILAG) A or B, unless within the constitutional, musculoskeletal and/or mucocutaneous domains
Other protocol-defined inclusion/exclusion criteria apply
Trial design
Primary purpose
Allocation
Interventional model
Masking
13 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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