A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

Phase 3

Recruiting

• Conditions: Systemic Lupus Erythematosus
• Interventions: Other: Placebo; Drug: Deucravacitinib

• Registration Number: NCT05617677
• 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

Study Timeline

• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-11-08
• Study First Posted: 2022-11-15
• Study Start: 2023-01-12
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-23
• Primary Completion: 2025-12-17
• Study Completion: 2027-12-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 490

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: Placebo	Placebo	-
Arm 1: Deucravacitinib	Deucravacitinib	-

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 AEs leading to discontinuation of treatment	Up to 156 weeks
Number of participants with target adverse events of special interest (AESIs)	Up to 156 weeks
Number of participants with electrocardiogram (ECG) abnormalities	Up to 156 weeks
Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response	At week 52
Proportion of participants who achieve both SRI(4) and BICLA (dual responders)	At week 52
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
Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS)	At week 52
Number of participants with adverse events (AEs)	Up to 156 weeks
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
Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue	At week 52
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
Number of participants with serious adverse events (SAEs)	Up to 156 weeks
Number of participants with AEs leading to study discontinuation	Up to 156 weeks
Number of participants with laboratory abnormalities	Up to 156 weeks
Number of participants with vital sign abnormalities	Up to 156 weeks

Trial Locations

Locations (220)

Local Institution - 0247; 🇺🇸 La Mesa, California, United States

Local Institution - 0248; 🇺🇸 Sacramento, California, United States

Local Institution - 0249; 🇺🇸 Coral Springs, Florida, United States

Discovery Health Research; 🇺🇸 Plantation, Florida, United States

Local Institution - 0250; 🇺🇸 Houston, Texas, United States

Stat Research S.A.; 🇦🇷 Ciudad Autónoma de Buenos Aires, Argentina

Local Institution - 0243; 🇮🇳 Surat, Gujarat, India

Local Institution - 0252; 🇵🇷 San Juan, Puerto Rico

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Local Institution - 0229; 🇺🇸 Phoenix, Arizona, United States

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