Summary

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

Description

Summary

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)

Keywords

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

Eligibility

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

Locations

  • 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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT04857034
Phase
Phase 2 Lupus Research Study
Study Type
Interventional
Participants
Expecting 75 study participants
Last Updated