Trials / Active Not Recruiting
Active Not RecruitingNCT05617677
A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-1)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 516 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Deucravacitinib | Specified dose on specified days |
| OTHER | Placebo | Specified dose on specified days |
Timeline
- Start date
- 2023-01-12
- Primary completion
- 2026-10-19
- Completion
- 2028-11-13
- First posted
- 2022-11-15
- Last updated
- 2025-12-03
Locations
197 sites across 22 countries: United States, Argentina, Brazil, Bulgaria, Canada, China, Colombia, France, Germany, Hong Kong, India, Ireland, Italy, Lithuania, Mexico, Moldova, Peru, Poland, Puerto Rico, Romania, South Korea, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05617677. Inclusion in this directory is not an endorsement.