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 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.

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

April 2 2026

Active Locations (350)

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Page 1 of 88 (350 locations)

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