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

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: BMS-986165

Study type: Interventional

Funder types: Industry

Identifiers

NCT03920267

IM011-074

2018-003471-35 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 261 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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261 participants in 3 patient groups

BMS-986165 Dose 1

Experimental group

Treatment:

Drug: BMS-986165

BMS-986165 Dose 2

Experimental group

Treatment:

Drug: BMS-986165

BMS-986165 Dose 3

Experimental group

Treatment:

Drug: BMS-986165