Deucravacitinib for Lupus

Recruiting in Palo Alto (17 mi)

+194 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Bristol-Myers Squibb

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new medication called BMS-986165 to see if it is safe and can be tolerated by people with Systemic Lupus Erythematosus (SLE).

Eligibility Criteria

This trial is for people who have completed a previous SLE study (NCT03252587) and are currently on the blinded study drug. Exceptions may be made for those who missed doses due to special circumstances like COVID-19, with approval from the trial physician.

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

There are other requirements or restrictions for participating in the study that are defined in the study's protocol.

I have active tuberculosis.

Participant Groups

The focus of this study is on BMS-986165's long-term safety and effectiveness in treating Systemic Lupus Erythematosus. Participants will continue using this medication over an extended period to monitor its ongoing impact.

3Treatment groups

Experimental Treatment

Group I: BMS-986165 Dose 3Experimental Treatment1 Intervention

Group II: BMS-986165 Dose 2Experimental Treatment1 Intervention

Group III: BMS-986165 Dose 1Experimental Treatment1 Intervention