NCT07116967
Recruiting
Phase 3
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
Bristol-Myers Squibb692 sites in 1 country3,040 target enrollmentStarted: September 22, 2025Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 3,040
- Locations
- 692
- Primary Endpoint
- Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization
Overview
Brief Summary
A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants with moderate-to-severe plaque psoriasis:
- •Deemed by the Investigator to be a candidate for phototherapy or systemic treatment for psoriasis, including ustekinumab;
- •Have at least 1 of the following cardiovascular risk factors:
- •Current cigarette smoker
- •Diagnosis of hypertension
- •Diagnosis of hyperlipidemia
- •Diabetes mellitus type 1 or 2
- •History of one or more of the following cardiovascular events: Coronary intervention (PCI) or coronary artery bypass grafting (CABG), myocardial infarction (heart attack), cardiac arrest, hospitalization for unstable angina, acute coronary syndrome, stroke, or transient ischemic attack
- •Family history of premature coronary heart disease or sudden death in a first-degree male relative younger than 55 years of age or in a first-degree female relative younger than 65 years of age.
Exclusion Criteria
- •Participants must not have recent history of 1 of the following cardiovascular events: MI, stroke, or coronary revascularization, or VTE within 90 days prior to Day
- •Participants must not have unstable CVD, defined as a recent clinical cardiovascular event (eg, unstable angina, rapid atrial fibrillation), or a cardiac hospitalization (eg, pacemaker implantation, HF) within 90 days prior to Day
- •Participants must not have evidence of active cancer or history of cancer (solid organ or hematologic malignancy including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell or squamous cell carcinoma, or carcinoma of cervix in situ that has been treated with no evidence of recurrence).
- •Other protocol define inclusion/exclusion criteria apply.
Arms & Interventions
Arm A
Experimental
Intervention: Deucravacitinib (Drug)
Arm B
Active Comparator
Intervention: Ustekinumab (Drug)
Outcomes
Primary Outcomes
Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization
Time Frame: Up to 5 years
MACE defined as non-fatal myocardial infarction \[MI\], nonfatal stroke, and cardiovascular death
Secondary Outcomes
- Number of participants with composite venous thromboembolism (VTE)(Up to 5 years)
- Number of participants with heart failure (HF) requiring hospitalization or urgent visit(Up to 5 years)
- All-cause mortality(Up to 60 days after last dose)
- Death due to cardiovascular events(Up to 5 years)
- All-cause mortality(Up to 60 days after last dose)
- Number of participants with non-fatal MI(Up to 5 years)
- Number of participants with coronary revascularization(Up to 5 years)
- Number of participants with composite venous thromboembolism (VTE)(Up to 5 years)
- Number of participants with arterial thromboembolic events (including retinal artery occlusion)(Up to 5 years)
- Number of participants with heart failure (HF) requiring hospitalization or urgent visit(Up to 5 years)
- Number of participants with opportunistic infections(Up to 5 years)
- Number of participants with non-fatal stroke(Up to 5 years)
- Number of participants with pulmonary embolism (PE)(Up to 5 years)
- Number of participants with deep vein thrombosis (DVT)(Up to 5 years)
- Number of participants with Serious AEs (SAEs)(Up to 60 days after last dose)
- AEs leading to permanent treatment discontinuation(Up to 60 days after last dose)
- Change from baseline in liver function test(Up to 60 days after last dose)
- Change from baseline in fasting lipid panel(Up to 60 days after last dose)
- Number of participants with 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death)(Up to 5 years)
- Number of participants with Malignancy excluding non-melanoma skin cancer (NMSC)(Up to 5 years)
- Number of participants with NMSC(Up to 5 years)
Investigators
Study Sites (692)
Loading locations...
Similar Trials
Active, not recruiting
Phase 3
A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusNCT05617677Bristol-Myers Squibb516
Active, not recruiting
Phase 3
A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusNCT05620407Bristol-Myers Squibb513
Completed
Phase 2
A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative ColitisCrohn DiseaseUlcerative ColitisNCT04877990Bristol-Myers Squibb67
Completed
Phase 4
Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp PsoriasisPsoriasisNCT05478499Bristol-Myers Squibb154
Completed
Not Applicable
Long-term Safety and Efficacy of Deucravacitinib in Participants with Crohn's Disease or Ulcerative Colitis (IM011-077)jRCT2031210637Bristol-Myers Squibb15