A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus
NCT05620407 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 513
Last updated 2025-12-02
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
- QUADRUPLE
- 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
- Australia
- Brazil
- Bulgaria
- Chile
- Czechia
- Greece
- Hungary
- India
- Japan
- Mexico
- Peru
- Poland
- Portugal
- Puerto Rico
- Singapore
- Spain
- Taiwan
- Thailand
- Turkey (Türkiye)
- United Kingdom
Study Locations
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