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

Study Overview
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Brief Summary
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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
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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)

Conditions
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Lupus Erythematosus, Discoid, Lupus Erythematosus, Subacute Cutaneous

Intervention / Treatment
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* Drug: Deucravacitinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Treatment: Deucravacitinib Dose 1<br> | Drug: Deucravacitinib<br>* Specified dose on specified days<br>|
| Experimental: Active Treatment: Deucravacitinib Dose 2<br> | Drug: Deucravacitinib<br>* Specified dose on specified days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score at week 16 |  | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with an improvement of ≥ 50% from baseline in the CLASI-A score (CLASI- 50) |  | Week 16 | 
| Percentage of participants who have disease improvement as defined by a reduction in CLASI-A of ≥ 4 points from baseline |  | Week 16 | 
| Mean change from baseline in CLASI-A score |  | Week 16 | 
| Percentage of participants who have a Complete Response (CR) on CLASI-A defined as a score of 0 |  | Week 16 | 
| Incidence of serious adverse events (SAEs) |  | Up to 60 weeks | 
| Incidence of adverse events (AEs) |  | Up to 56 weeks | 
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests |  | Up to 56 weeks | 
| Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests |  | Up to 56 weeks | 
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis |  | Up to 56 weeks | 
| Incidence of clinically significant changes in vital signs: Body temperature |  | Up to 56 weeks | 
| Incidence of clinically significant changes in vital signs: Respiratory rate |  | Up to 56 weeks | 
| Incidence of clinically significant changes in vital signs: Blood pressure |  | Up to 56 weeks | 
| Incidence of clinically significant changes in vital signs: Heart rate |  | Up to 56 weeks | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval | PR interval: The time from the onset of the P wave to the start of the QRS complex | Up to 56 weeks | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval | QRS interval: A combination of the Q wave, R wave and S wave, the QRS complex represents ventricular depolarization | Up to 56 weeks | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval | QT interval: Measured from the beginning of the QRS complex to the end of the T wave | Up to 56 weeks | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval | QTcF interval: Corrected QT interval using Fridericia's formula (QTcF) | Up to 56 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-986165, Deucravacitinib, DLE, Discoid Lupus Erythematosus, SCLE, Subacute Cutaneous Lupus Erythematosus