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Active, Not Recruiting

A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus - IM026-027

Updated: 7 February, 2023   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
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Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.
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Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18-65

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: BMS-986256
Drug: BMS-986256
Placebo Comparator: Placebo
Other: BMS-986256 Placebo

Key Eligibility Criteria

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

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Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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