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

  • days left to enroll
  • participants needed
  • sponsor
    Bristol-Myers Squibb
Updated on 4 October 2022
skin lesion
drug levels
systemic lupus erythematosus


The purpose of this study is to assess the safety and drug levels of BMS-986256 in participants with cutaneous lupus erythematosus.

Condition Lupus Erythematosus, Cutaneous
Treatment BMS-986256, BMS-986256 Placebo
Clinical Study IdentifierNCT04493541
SponsorBristol-Myers Squibb
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

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
Any British Isles Lupus Assessment Group (BILAG) A or B, unless within the
Active, severe Lupus Nephritis (LN)
constitutional, musculoskeletal and/or mucocutaneous domains
Other protocol-defined inclusion/exclusion criteria 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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