Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus
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Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
261actual
Sites
98
Countries
Argentina, Brazil, Canada +11
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-03-26 | actual | When the study began enrolling |
| Primary completion | 2025-03-21 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-03-21 | actual | The whole study's end, after follow-up |
| First posted | 2019-04-18 | actual | When this record first appeared on the registry |
| Results posted | 2026-03-20 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-03-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Systemic Lupus Erythematosus
Intervention
- Drug: BMS-986165 — also filed as Deucravacitinib
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants With Treatment-Emergent Adverse Events and Treatment Emergent Serious Adverse Events
measured From Day 1 until 30 days after last dose (up to approximately 42 months)
Number of Participants With Abnormalities in Vital Signs
measured From Day 1 until 30 days after last dose (up to approximately 42 months)
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
measured From Day 1 until 30 days after last dose (up to approximately 42 months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2021-01-15 · 6.8 MB · Prot_SAP_000.pdf
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