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

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 2

Conditions: Lupus Erythematosus, Subacute Cutaneous; Lupus Erythematosus, Discoid

Treatments: Drug: Deucravacitinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04857034

2020-000071-21 (EudraCT Number)

U1111-1246-1726 (Registry Identifier)

IM011-132

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups, including a placebo group

Active Treatment: Deucravacitinib Dose 1

Experimental group

Treatment:

Drug: Deucravacitinib

Active Treatment: Deucravacitinib Dose 2

Experimental group

Treatment:

Drug: Deucravacitinib

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo