NCT07116967 · Bristol-Myers Squibb
Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
What this study is about
A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
View original scientific description
A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
Interventions
DRUG
Deucravacitinib
Specified dose on specified days
DRUG
Ustekinumab
Specified dose on specified days
Primary outcome measures
Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization
Time frame: Up to 5 years
MACE defined as non-fatal myocardial infarction \[MI\], nonfatal stroke, and cardiovascular death
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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,
Where
- Birmingham, Alabama
- Phoenix, Arizona
- Scottsdale, Arizona
- Tempe, Arizona
- Fayetteville, Arkansas
- Rogers, Arkansas
- Encinitas, California
- Encino, California
- Fountain Valley, California
- Fremont, California
- Huntington Beach, California
- Los Angeles, California
And 92 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations