Active, Not Recruiting

Trial ID IM011-074 | NCT03920267

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

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About This Trial
Key Eligibility Criteria

Summary

Phase 2
18-75

Age Range
Active, Not Recruiting

Overview

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).

Key Eligibility Criteria

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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: BMS-986165 Dose 1

ASSIGNED INTERVENTION

Drug: BMS-986165

Study Arms

Experimental: BMS-986165 Dose 2

ASSIGNED INTERVENTION

Drug: BMS-986165

Study Arms

Experimental: BMS-986165 Dose 3

ASSIGNED INTERVENTION

Drug: BMS-986165