A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Other: Placebo
- Registration Number
- NCT05620407
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 490
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Deucravacitinib Deucravacitinib - Arm 2: Placebo Placebo -
- Primary Outcome Measures
Name Time Method Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response At week 52
- Secondary Outcome Measures
Name Time Method Number of participants with target adverse events of special interest (AESIs) Up to 156 weeks Number of participants with laboratory abnormalities Up to 156 weeks Proportion of participants taking ≤ 7.5 mg/day prednisone (or equivalent) at Week 24 with no dose increase beyond protocol-specified limits Up to 52 weeks Number of participants with AEs leading to discontinuation of treatment Up to 156 weeks Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response At week 52 Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue At week 52 Number of participants with AEs leading to study discontinuation Up to 156 weeks Proportion of participants who achieve both SRI(4) and BICLA (dual responders) At week 52 Proportion of participants with ≥ 6 active (tender + swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints At week 52 Number of participants with adverse events (AEs) Up to 156 weeks Number of participants with serious adverse events (SAEs) Up to 156 weeks Number of participants with electrocardiogram (ECG) abnormalities Up to 156 weeks Number of participants with vital sign abnormalities Up to 156 weeks Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score At week 52 Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS) At week 52
Trial Locations
- Locations (207)
Local Institution - 0237
🇺🇸Searcy, Arkansas, United States
UCSD - Altman Clinical and Translational Research Institute (ACTRI)
🇺🇸La Jolla, California, United States
Purushotham & Akther Kotha MD, Inc
🇺🇸La Mesa, California, United States
Rheumatology Center of San Diego
🇺🇸San Diego, California, United States
East Bay Rheumatology Medical Group, Inc
🇺🇸San Leandro, California, United States
Providence Saint John's Medical Foundation
🇺🇸Santa Monica, California, United States
Clinical Research of West Florida, Inc. (Clearwater)
🇺🇸Clearwater, Florida, United States
UF Health Deerwood Park
🇺🇸Jacksonville, Florida, United States
Life Clinical Trials
🇺🇸Margate, Florida, United States
Nuline Clinical Trial Center
🇺🇸Oakland Park, Florida, United States
Scroll for more (197 remaining)Local Institution - 0237🇺🇸Searcy, Arkansas, United States