Adults aged 18 to 75 with a diagnosis of active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE) for at least 3 months, may qualify to participate. Individuals must have active moderate to severe cutaneous lupus to be eligible for study entry. They must also currently be receiving treatment with a stable regimen of at least one of the following medications: an oral corticosteroid, and/or an antimalarial, and/or an immunosuppressant.
Participants will receive one of two dosages of investigational oral medication (active study drug) or placebo for 16 weeks. At Week 16, participants who previously received placebo will then receive one of two dosages of active study drug. Study medication and study-related procedures will be provided at no cost. Reimbursement for study-related expenses will also be provided.
Study participation will last about 60 weeks and involve about 12 visits to the study centre.
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Last Update Posted: September 24, 2023
NCT04857034
Bristol-Myers Squibb
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 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.
Condition or Disease:
Lupus Erythematosus, Discoid
Intervention/Treatment:
Drug: DeucravacitinibPhase:
Phase 2
Ages Eligible for Study:
18 Years and 75 Years (Adult)
Sexes Eligible for Study:
All
Inclusion Criteria:
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 Criteria:
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
Terms and Conditions – ClinicalTrials.gov
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