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

Phase 2

Active, not recruiting

Conditions: Lupus Erythematosus, Discoid
Lupus Erythematosus, Subacute Cutaneous

Interventions: Drug: Deucravacitinib
Drug: Placebo

Registration Number: NCT04857034

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 74

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Treatment: Deucravacitinib Dose 1	Deucravacitinib	-
Active Treatment: Deucravacitinib Dose 2	Deucravacitinib	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in CLASI Activity Score at Week 16	From first dose to Week 16 (approximately 16 weeks)	The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With an Improvement of ≥ 50% From Baseline in the CLASI-A Score (CLASI-50).	From first dose to Week 16 (approximately 16 weeks)	The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70
Percentage of Participants Who Have Disease Improvement as Defined by a Reduction in CLASI-A of ≥ 4 Points From Baseline.	From first dose to Week 16 (approximately 16 weeks)	The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70
Mean Change From Baseline in CLASI-A Score.	From first dose to Week 16 (approximately 16 weeks)	The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70
Percentage of Participants Who Have a Complete Response (CR) on CLASI-A Defined as a Score of "0".	From first dose to Week 16 (approximately 16 weeks)	The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70 Complete Response (CR) on CLASI-A defined as a score of "0".
Number of Participants With Safety Related Events in the Placebo Controlled Period	From signing informed consent to end of safety follow up period (Approximately 60 weeks)	Number of participants with safety related events in the placebo controlled period
Number of Participants With Safety Related Events in the Active Treatment Period	From signing informed consent to end of safety follow up period (Approximately 60 weeks)	Number of participants with safety related events in the active treatment period
Number of Participants With Clinically Significant Laboratory Abnormalities in the Placebo Controlled Period	From signing informed consent to end of safety follow up period (Approximately 60 weeks)	Number of participants with clinically significant laboratory abnormalities in the placebo controlled period
Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period	From signing informed consent to end of safety follow up period (Approximately 60 weeks)	Number of participants with clinically significant laboratory abnormalities in the active treatment period
Number of Participants With Clinically Significant Vital Sign Abnormalities in the Placebo Controlled Period	From signing informed consent to end of safety follow up period (Approximately 60 weeks)	Number of participants with clinically significant vital sign abnormalities in the placebo controlled period
Number of Participants With Clinically Significant Vital Sign Abnormalities in the Active Treatment Period	From signing informed consent to end of safety follow up period (Approximately 60 weeks)	Number of participants with clinically significant vital sign abnormalities in the active treatment period
Number of Participants With Clinically Significant ECG Abnormalities in the Placebo Controlled Period	From signing informed consent to end of active treatment period (Approximately 56 weeks)	Number of participants with clinically significant ECG abnormalities in the placebo controlled period
Number of Participants With Clinically Significant ECG Abnormalities in the Active Treatment Period	From signing informed consent to end of active treatment period (Approximately 56 weeks)	Number of participants with clinically significant ECG abnormalities in the active treatment period

Trial Locations

Locations (41): Local Institution - 0077
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Scottsdale, Arizona, United States
Local Institution - 0076
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Irvine, California, United States
Local Institution - 0046
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Los Angeles, California, United States
Local Institution - 0073
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Farmington, Connecticut, United States
Local Institution - 0082
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Orlando, Florida, United States
Local Institution - 0060
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Ann Arbor, Michigan, United States
Local Institution - 0059
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St Louis, Missouri, United States
Local Institution - 0037
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New York, New York, United States
Local Institution - 0065
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Durham, North Carolina, United States
Local Institution - 0067
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Columbus, Ohio, United States
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Local Institution - 0077
🇺🇸Scottsdale, Arizona, United States