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

Completed · Phase 2

Conditions studied: Systemic Lupus Erythematosus

In brief

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 facts

Study ID

NCT03920267

Run by

Bristol-Myers Squibb

People needed

261

Starts

2019-03-26

Expected to finish

2025-03-21

Last updated by the study team

2026-03-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Local Institution - 0030 — El Cajon, California, United States
• Local Institution - 0049 — Torrance, California, United States
• Local Institution - 0074 — New Haven, Connecticut, United States
• Local Institution - 0115 — Aventura, Florida, United States
• Local Institution - 0044 — Brandon, Florida, United States
• Local Institution - 0140 — Gainesville, Florida, United States
• Local Institution - 0133 — Orlando, Florida, United States
• Local Institution - 0032 — Ormond Beach, Florida, United States
• Local Institution - 0048 — Tampa, Florida, United States
• Local Institution - 0094 — Atlanta, Georgia, United States
• Local Institution - 0050 — Lawrenceville, Georgia, United States
• Local Institution - 0123 — Brooklyn, New York, United States
• Local Institution - 0131 — New York, New York, United States
• Local Institution - 0071 — Chapel Hill, North Carolina, United States
• Local Institution - 0031 — Charlotte, North Carolina, United States
• Local Institution - 0064 — Oklahoma City, Oklahoma, United States
• Local Institution - 0035 — Wyomissing, Pennsylvania, United States
• Local Institution - 0121 — Charleston, South Carolina, United States
• Local Institution - 0001 — Jackson, Tennessee, United States
• Local Institution - 0041 — Austin, Texas, United States
• Tekton Research - Austin — Austin, Texas, United States
• Local Institution - 0114 — Dallas, Texas, United States
• Local Institution - 0037 — Houston, Texas, United States
• Local Institution - 0046 — Mesquite, Texas, United States
• Local Institution - 0077 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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