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

NCT07116967

RecruitingPhase 3

Sponsor: Bristol-Myers Squibb

Conditions: Plaque Psoriasis

Interventions: Deucravacitinib, Ustekinumab

Countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile

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

Eligibility overview

Sex: ALL

Age: 40 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (394)

Birmingham, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Scottsdale, Arizona, United States
Scottsdale, Arizona, United States
Tempe, Arizona, United States
Fayetteville, Arkansas, United States
Rogers, Arkansas, United States
Encinitas, California, United States
Encino, California, United States
Fountain Valley, California, United States
Fremont, California, United States
Huntington Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Northridge, California, United States
Palmdale, California, United States
Pasadena, California, United States
Pomona, California, United States
Sacramento, California, United States
Sacramento, California, United States
San Diego, California, United States
Santa Clarita, California, United States
Santa Monica, California, United States
Sherman Oaks, California, United States
Sherman Oaks, California, United States
Walnut Creek, California, United States
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