A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants With Moderate-to-Severe Plaque Psoriasis
NCT: NCT07116967 ·
Status: RECRUITING ·
Phase: Phase 3
· Sponsor: Bristol-Myers Squibb
· Started: 2025-09-22
· Est. Completion: 2031-01-16
Official Summary
A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 3,040 participants
Interventions
- DRUG: Deucravacitinib — Specified dose on specified days
- DRUG: Ustekinumab — Specified dose on specified days
Primary Outcomes
- Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization (Up to 5 years)
Secondary Outcomes
- Number of participants with non-fatal MI (Up to 5 years)
- Number of participants with non-fatal stroke (Up to 5 years)
- Death due to cardiovascular events (Up to 5 years)
- Number of participants with coronary revascularization (Up to 5 years)
- Number of participants with 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death) (Up to 5 years)
Trial Locations
- Local Institution - 0088, Birmingham, Alabama, United States
- Medical Dermatology Specialists - Phoenix, Phoenix, Arizona, United States
- Saguaro Dermatology - Phoenix, Phoenix, Arizona, United States
- Omni Dermatology, Phoenix, Arizona, United States
- Alliance Dermatology, Phoenix, Arizona, United States
- Local Institution - 0322, Scottsdale, Arizona, United States
- Local Institution - 0188, Scottsdale, Arizona, United States
- Scottsdale Clinical Trials, Scottsdale, Arizona, United States
- Omni Dermatology, Tempe, Arizona, United States
- Clinical Trials Institute of Northwest Arkansas, Fayetteville, Arkansas, United States
- ...and 10 more locations
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AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.