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Long-term safety of deucravacitinib versus ustekinumab for plaque psoriasis (PRAGMATYK)

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

Phase 3 Interventional Bristol-Myers Squibb · NCT07116967

This study will test whether deucravacitinib or ustekinumab has better long-term safety for adults with moderate-to-severe plaque psoriasis who have cardiovascular risk factors.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment3040 (estimated)
Ages40 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Drugs / interventionsustekinumab, Deucravacitinib
Locations357 sites (Birmingham, Alabama and 356 other locations)
Trial IDNCT07116967 on ClinicalTrials.gov

What this trial studies

Participants with moderate-to-severe plaque psoriasis who are candidates for systemic therapy and who have at least one cardiovascular risk factor will receive either deucravacitinib or ustekinumab and be followed over time for safety outcomes. The primary focus is on long-term adverse events, including cardiovascular events, and overall tolerability of the two treatments. Eligible participants include current smokers, people with hypertension, hyperlipidemia, diabetes, obesity, prior cardiovascular events, or a family history of premature coronary disease. The trial is sponsored by Bristol-Myers Squibb and is conducted at selected U.S. dermatology centers.

Who should consider this trial

Good fit: Adults with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy and who have one or more cardiovascular risk factors (for example smoking, hypertension, high cholesterol, diabetes, obesity, prior cardiovascular event, or relevant family history).

Not a fit: Patients with only mild psoriasis who are not candidates for systemic therapy, or those with recent major cardiovascular events who are excluded from the trial, are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could identify which medicine carries lower long-term cardiovascular and overall safety risks for psoriasis patients with cardiovascular risk factors.

How similar studies have performed: Both deucravacitinib and ustekinumab have shown efficacy and acceptable safety in prior trials, but direct long-term comparisons focused on cardiovascular outcomes are limited, so this approach is partly novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 356 other locations

+307 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Plaque PsoriasisDeucravacitinibPlaque psoriasisCardiovascular riskPRAGMATYK
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.