Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Lupus Erythematosus, Discoid
Lupus Erythematosus, Subacute Cutaneous
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2028
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04857034
Start Date
July 12 2021
End Date
February 28 2028
Last Update
September 10 2025
Active Locations (41)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution - 0077
Scottsdale, Arizona, United States, 85259
2
Local Institution - 0076
Irvine, California, United States, 92697
3
Local Institution - 0046
Los Angeles, California, United States, 90045
4
Local Institution - 0073
Farmington, Connecticut, United States, 06030