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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Diagnosis of discoid/subacute cutaneous lupus erythematosus (DLE/SCLE) for at least 3 months prior to screening visit
  2. Meets both clinical and histopathological diagnostic cutaneous lupus erythematosus (CLE) criteria per protocol
  3. 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
  4. Participant could be with or without concurrent systemic lupus erythematosus (SLE)
  5. 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

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Women who are pregnant, lactating, breastfeeding or planning pregnancy during the study period
  2. Any of the following specific CLE subtypes in isolation: acute cutaneous lupus erythematosus (ACLE), lupus tumidus, lupus (profundus) panniculitis, chilblains
  3. Drug-induced CLE and/or drug-induced systemic lupus erythematosus (SLE)
  4. Antiphospholipid antibody syndrome, serious thrombotic event or unexplained pregnancy loss within 1 year before the screening visit
  5. History of 3 or more unexplained consecutive pregnancy losses
  6. Active severe or unstable neuropsychiatric SLE
  7. 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


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 855-907-3286Email iconEmail Study Center

Study Details


Contition
Lupus Erythematosus, Discoid,Lupus Erythematosus, Subacute Cutaneous
Age (in years)
18 - 75
Phase
Phase 2
Participants Needed
75
Est. Completion Date
Feb 27, 2026
Treatment Type
Interventional

Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov NCT Identifier
NCT04857034
Study Number
IM011132

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