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Recruiting NCT07116967

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

Conditions: Plaque Psoriasis

Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 3040
Sponsor: Bristol-Myers Squibb

Location: Local Institution - 0088 Birmingham Alabama

Summary

A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis

Eligibility Criteria

Inclusion Criteria: * Participants with moderate-to-severe plaque psoriasis: 1. Deemed by the Investigator to be a candidate for phototherapy or systemic treatment for psoriasis, including ustekinumab; 2. 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 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 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07116967). StuddyBuddy aggregates publicly available trial information.