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Long-Term Safety Study for Psoriasis Treatment

This study is looking at the long-term safety of two medicines, Deucravacitinib and Ustekinumab, for people with moderate-to-severe plaque psoriasis. Researchers want to see how these treatments affect your heart health over time. You might be able to join if you are 40 years or older, have plaque psoriasis that needs treatment, and have at least one heart disease risk factor like smoking, high blood pressure, high cholesterol, or diabetes. The main goal is to track serious heart-related events over up to five years. The study plans to include 3040 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 3040 participants. It compares Deucravacitinib to Ustekinumab.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to measure heart-related events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07116967

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

Recruiting
PHASE3Ages 40+InterventionalTreatment
Bristol-Myers Squibb
~3,040 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:DeucravacitinibUstekinumab

At a glance

Recruiting sites
303 of 402 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization
Measured over Up to 5 years

Conditions

Plaque Psoriasis

Explore related trials

Chronic small plaque psoriasis

Where it's being run

402 sites across 155 states
California19
Ontario17
Germany17
Poland14
Florida11
Bulgaria10
Czechia9
Arizona8

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants with moderate-to-severe plaque psoriasis:
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

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).

What this trial measures

  • Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularizationUp to 5 years

    MACE defined as non-fatal myocardial infarction \[MI\], nonfatal stroke, and cardiovascular death