Status:
COMPLETED
A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Lupus Erythematosus, Cutaneous
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety and drug levels of BMS-986256 in participants with cutaneous lupus erythematosus.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04493541
Start Date
August 26 2020
End Date
April 21 2023
Last Update
May 9 2023
Active Locations (1)
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1
Local Institution - 0001
Berlin, Germany, 10117