Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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The main objective of the trial is to characterize the long-term safety and tolerability of BMS-986165 in subjects with Systemic Lupus Erythematosus (SLE).

Official Title
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A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus Erythematosus

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: BMS-986165


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completion of SLE Study (NCT03252587) through the protocol-required treatment period, and currently receiving blinded study drug. Note: If a subject is not receiving blinded study drug due to exceptional circumstances (eg, missed investigational product [IP] due to COVID-19 pandemic, delays in study approval, etc), the subject may be allowed to enroll with approval from the BMS Clinical Trial Physician or designee. Exclusion Criteria: Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or considered unsuitable by the investigator for any other reason Evidence of active tuberculosis (TB) 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
Interventional Model Description: Participants who successfully complete the protocol-required treatment period of the Phase 2 SLE study (NCT03252587) will be offered the opportunity to continue this study.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986165 Dose 1<br> | Drug: BMS-986165<br>* Specified dose on specified days<br>* Other names: Deucravacitinib;|
| Experimental: BMS-986165 Dose 2<br> | Drug: BMS-986165<br>* Specified dose on specified days<br>* Other names: Deucravacitinib;|
| Experimental: BMS-986165 Dose 3<br> | Drug: BMS-986165<br>* Specified dose on specified days<br>* Other names: Deucravacitinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events (AEs) |  | Up to 30 days after last treatment dose (approximately 178 weeks) | 
| Number of participants with Serious Adverse Events (SAEs) |  | Up to 30 days after last treatment dose (approximately 178 weeks) | 
| Number of participants with AEs leading to discontinuation |  | Up to 30 days after last treatment dose (approximately 178 weeks) | 
| Number of participants with abnormal change from baseline in laboratory measurements over time |  | Up to 30 days after last treatment dose (approximately 178 weeks) | 
| Number of participants with abnormal change from baseline in vital signs over time |  | Up to 30 days after last treatment dose (approximately 178 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic Lupus Erythematosus