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Trial ID IM011-1130  |   NCT07116967

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

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Summary

  • Phase 3
  • Male and Female Gender icon
  • 40+
    Age Range
  • 156
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

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

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • 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:
    1. Current cigarette smoker
      1. Diagnosis of hypertension
        1. Diagnosis of hyperlipidemia
          1. Diabetes mellitus type 1 or 2
            1. 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
              1. Obesity
                1. 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

                  Exclusion Criteria Icon
                  :
                  • 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.
                    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.
                      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).
                        1. Other protocol define inclusion/exclusion criteria apply.
                          Additional Information *

                          Treatment Options

                          Study Arms

                          ASSIGNED INTERVENTION

                          Study Arms

                          Experimental: Arm A

                          ASSIGNED INTERVENTION
                          • Drug: Deucravacitinib

                          Study Arms

                          Active Comparator: Arm B

                          ASSIGNED INTERVENTION
                          • Drug: Ustekinumab
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