RecruitingPhase 3

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

A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants With Moderate-to-Severe Plaque Psoriasis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares the long-term safety of deucravacitinib and ustekinumab. It is for people with moderate-to-severe plaque psoriasis, which causes thick, scaly skin patches, who have at least one risk factor for heart or blood vessel disease.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have moderate-to-severe plaque psoriasis.
  • The study doctor thinks you can receive light therapy or medicine that treats psoriasis throughout the body, including ustekinumab.
  • Have at least one of these risk factors: current cigarette smoking, high blood pressure, high cholesterol or other blood fats, type 1 or type 2 diabetes, or obesity.
  • A past heart or blood vessel event also counts as a risk factor: a procedure or bypass surgery to improve blood flow to the heart, heart attack, heart stopping, a hospital stay for worsening heart-related chest pain, a sudden problem with blood flow to the heart, stroke, or mini-stroke.
  • Family history also counts as a risk factor: early heart artery disease or sudden death in a parent, sibling, or child—before age 55 for males or age 65 for females.
  • Other study entry rules apply.

Who can't join

  • Had a heart attack, stroke, procedure to restore blood flow to the heart, or blood clot in a vein within 90 days before the first study day.
  • Have unstable heart or blood vessel disease, such as worsening heart-related chest pain or a fast, irregular heartbeat, within 90 days before the first study day.
  • Had a heart-related hospital stay, such as for a pacemaker or heart failure, within 90 days before the first study day.
  • Have active cancer, or had cancer or a disease that causes too many lymph cells within the past 5 years. This includes cancers of organs, blood, or bone marrow.
  • Exceptions to the cancer rule include removed basal cell or squamous cell skin cancer, or treated early cancer limited to the surface of the cervix that has not returned.
  • Other study exclusion rules apply.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (122)

AL

AR

AZ

CA

CO

DC

FL

GA

IL

IN

KY

LA

MA

MD

MI

MN

MO

NC

NE

NH

NJ

NV

NY

OH

OK

OR

PA

SC

SD

TN

TX

VA

WA