Phase 2
Completed N=261
Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Source: ClinicalTrials.gov NCT03920267 ↗
Enrolled (actual)
261
Serious AEs
15.3%
Results posted
Mar 2026
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events and Treatment Emergent Serious Adverse Events — 51; 63; 62; 21 Participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events and Treatment Emergent Serious Adverse Events |
51; 63; 62; 21; 19; 18 | — |
| PRIMARY Number of Participants With Abnormalities in Vital Signs |
2; 1; 1; 0; 1; 1 | — |
| PRIMARY Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities |
0; 2; 1; 0; 0; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT03920267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.