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

Recruiting now · Phase 3

Conditions studied: Plaque Psoriasis

In brief

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

Key facts

Study ID

NCT07116967

Run by

Bristol-Myers Squibb

People needed

3040

Starts

2025-09-22

Expected to finish

2031-01-16

Last updated by the study team

2026-07-23

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Medical Dermatology Specialists - Phoenix — Phoenix, Arizona, United States (enrolling)
• Advanced Dermatology and Skin Cancer Institute - Beverly Hills — Sherman Oaks, California, United States (enrolling)
• Omni Dermatology — Phoenix, Arizona, United States (enrolling)
• Alliance Dermatology — Phoenix, Arizona, United States (enrolling)
• Cura Clinical Research - Santa Clarita — Santa Clarita, California, United States (enrolling)
• Institute of Clinical Research and Consulting, Inc., d/b/a Clinical Science Institute — Santa Monica, California, United States (enrolling)
• Scottsdale Clinical Trials — Scottsdale, Arizona, United States (enrolling)
• Omni Dermatology — Tempe, Arizona, United States (enrolling)
• Clinical Trials Institute of Northwest Arkansas — Fayetteville, Arkansas, United States (enrolling)
• Northwest Arkansas Clinical Trials Center (NWACTC), PLLC — Rogers, Arkansas, United States (enrolling)
• Saguaro Dermatology - Phoenix — Phoenix, Arizona, United States (enrolling)
• T. Joseph Raoof MD Inc — Encino, California, United States (enrolling)
• First OC Dermatology - Fountain Valley — Fountain Valley, California, United States (enrolling)
• Center For Dermatology Clinical Research, Inc. — Fremont, California, United States (enrolling)
• Marvel Clinical Research — Huntington Beach, California, United States (enrolling)
• Dermatology Research Associates - Howard Sofen, MD — Los Angeles, California, United States (enrolling)
• Wallace Skin & Body Institute — Los Angeles, California, United States (enrolling)
• Northridge Clinical Trials - Elite Clinical Network — Northridge, California, United States (enrolling)
• Cura Clinical Research - Palmdale — Palmdale, California, United States (enrolling)
• Pasadena Clinical Trials — Pasadena, California, United States (enrolling)
• Empire Clinical Research - Pomona — Pomona, California, United States (enrolling)
• Integrative Skin Science and Research — Sacramento, California, United States (enrolling)
• UC Davis Dermatology Clinic — Sacramento, California, United States (enrolling)
• California Dermatology & Clinical Research Institute — Encinitas, California, United States (enrolling)
• Unison Clinical Trials — Sherman Oaks, California, United States (enrolling)

Full record on ClinicalTrials.gov

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