A Study to Evaluate Efficacy and Safety of BMS-986165 in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

• Status: Recruiting
• Trial end date: 2024-07-03
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety, efficacy, and tolerability of BMS-986165 compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE). This study will also assess if BMS-986165 is biologically active and potentially effective in the treatment of participants with moderate to severe DLE/SCLE with or without systemic lupus erythematosus (SLE) that is not well controlled with standard of care therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: BMS-986165

Criteria

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

Inclusion Criteria:

• Diagnosis of discoid/subacute cutaneous lupus erythematosus (DLE/SCLE) for at least 3 months prior to screening visit

• Meets both clinical and histopathological diagnostic cutaneous lupus erythematosus (CLE) criteria per protocol

• Currently receiving treatment for DLE/SCLE with a stable regimen of at least one of the following medications: oral corticosteroid, and/or antimalarial, and/or immunosuppressant

Exclusion Criteria:

• Women who are pregnant, lactating, breastfeeding or planning pregnancy during the study period

• Any of the following specific CLE subtypes in isolation: acute cutaneous lupus erythematosus (ACLE), lupus tumidus, lupus (profundus) panniculitis, chilblains

• Drug-induced CLE and/or drug-induced systemic lupus erythematosus (SLE)

• Antiphospholipid antibody syndrome, serious thrombotic event or unexplained pregnancy loss within 1 year before the screening visit

• History of 3 or more unexplained consecutive pregnancy losses

• Active severe or unstable neuropsychiatric SLE

• Other autoimmune diseases or non-SLE driven inflammatory joint or skin disease or overlap syndromes as primary disease that in the opinion of the investigator will significantly impact the assessment of CLE/SLE disease manifestations and activity

Other protocol-defined inclusion/exclusion criteria apply