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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Medical Dermatology Specialists - Phoenix
  Phoenix, Arizona, United States Recruiting
• Saguaro Dermatology - Phoenix
  Phoenix, Arizona, United States Recruiting
• Omni Dermatology
  Phoenix, Arizona, United States Recruiting
• Alliance Dermatology
  Phoenix, Arizona, United States Recruiting
• Scottsdale Clinical Trials
  Scottsdale, Arizona, United States Recruiting
• Omni Dermatology
  Tempe, Arizona, United States Recruiting

+361 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• How safe and well ZP9830 works in people with plaque psoriasis over 8 weeks

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.