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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Lupus Erythematosus, Discoid, Lupus Erythematosus, Subacute Cutaneous

In brief

The purpose of this study is to assess the safety, efficacy, and tolerability of deucravacitinib (BMS-986165) compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE). This study will also assess if deucravacitinib 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.

Key facts

Study ID: NCT04857034
Run by: Bristol-Myers Squibb
People needed: 74
Starts: 2021-07-12
Expected to finish: 2028-02-28
Last updated by the study team: 2025-09-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Participant could be with or without concurrent systemic lupus erythematosus (SLE)
If participant receives nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics treatment then the participant must be on a stable dose 2 weeks prior to screening

You may not qualify if…

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

Where it is running

Local Institution - 0077 — Scottsdale, Arizona, United States
Local Institution - 0076 — Irvine, California, United States
Local Institution - 0046 — Los Angeles, California, United States
Local Institution - 0073 — Farmington, Connecticut, United States
Local Institution - 0082 — Orlando, Florida, United States
Local Institution - 0060 — Ann Arbor, Michigan, United States
Local Institution - 0059 — St Louis, Missouri, United States
Local Institution - 0037 — New York, New York, United States
Local Institution - 0065 — Durham, North Carolina, United States
Local Institution - 0067 — Columbus, Ohio, United States
Local Institution - 0026 — Oklahoma City, Oklahoma, United States
Local Institution - 0054 — Charleston, South Carolina, United States
Local Institution - 0018 — Capital Federal, Buenos Aires, Argentina
Local Institution - 0013 — San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution - 0019 — Buenos Aires, Argentina
Local Institution - 0003 — Botany, New South Wales, Australia
Local Institution - 0001 — Kogarah, New South Wales, Australia
Local Institution - 0002 — Camberwell, Victoria, Australia
Local Institution - 0007 — Clayton, Victoria, Australia
Local Institution - 0078 — Melbourne, Victoria, Australia
Local Institution - 0087 — Victoria Park, Western Australia, Australia
Local Institution - 0038 — Bordeaux, France
Local Institution - 0027 — Créteil, France
Local Institution - 0010 — Paris, France
Local Institution - 0072 — Dresden, Saxony, Germany

Full record on ClinicalTrials.gov

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