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

• Status: Recruiting
• Trial end date: 2022-01-03
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

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) ii) Biopsy-proven cutaneous lupus erythematosus (CLE)

• Active cutaneous lupus disease, defined as a modified Cutaneous Lupus Erythematosus Disease Area and Severity Index- Activity (mCLASI-A) score ≥ 6

• Active cutaneous lupus skin lesion(s) amenable to biopsy

• Women and men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

• Diagnosis of discoid lupus erythematosus (DLE) or subacute cutaneous lupus erythematosus (SCLE) without SLE.

• 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