Status:
RECRUITING
Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
Eligibility Criteria
Inclusion
- 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
- Obesity
- 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
- 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 1.
- 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 1.
- 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.
Key Trial Info
Start Date :
September 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 16 2031
Estimated Enrollment :
3040 Patients enrolled
Trial Details
Trial ID
NCT07116967
Start Date
September 22 2025
End Date
January 16 2031
Last Update
March 10 2026
Active Locations (341)
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1
Local Institution - 0088
Birmingham, Alabama, United States, 35249
2
Medical Dermatology Specialists - Phoenix
Phoenix, Arizona, United States, 85006-2722
3
Saguaro Dermatology - Phoenix
Phoenix, Arizona, United States, 85008
4
Omni Dermatology
Phoenix, Arizona, United States, 85018