for people ages 18-75 (full criteria)
at Irvine, California and other locations
study started
completion around



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.

Official Title

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)


Lupus Erythematosus, Discoid, Lupus Erythematosus, Subacute Cutaneous, BMS-986165, Deucravacitinib, DLE, Discoid Lupus Erythematosus, SCLE, Subacute Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus


You can join if…

Open to people ages 18-75

  • 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 CAN'T join 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


  • University of California, Irvine accepting new patients
    Irvine California 92697 United States
  • Local Institution - 0046 completed
    Los Angeles California 90045 United States
  • Mayo Clinic in Arizona - Scottsdale accepting new patients
    Scottsdale Arizona 85259 United States


accepting new patients
Start Date
Completion Date
Bristol-Myers Squibb
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
Phase 2 Lupus Research Study
Study Type
Expecting 75 study participants
Last Updated