A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
NCT05617677 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 516
Last updated 2025-12-03
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
- DRUG
-
Specified dose on specified days
- OTHER
-
Placebo
Specified dose on specified days
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-12
- Primary Completion
- 2026-10-19
- Completion
- 2028-11-13
- FDA Drug
- Yes
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)
Study Locations
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