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Compares treatment options for Plaque Psoriasis
Official title Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
ClinicalTrials.gov ID: NCT07116967
What this study is testing
What is Deucravacitinib?
Deucravacitinib is an investigational medicine, being studied as a potential treatment for plaque psoriasis.
Also referred to as SOTYKTU.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Participants with moderate-to-severe plaque psoriasis:
- Deemed by the Investigator to be a candidate for phototherapy or systemic treatment for psoriasis, including ustekinumab;
- Have at least 1 of the following cardiovascular risk factors:
- Current cigarette smoker
- Diagnosis of hypertension
You likely can't join if
- Participants must not have recent history of 1 of the following cardiovascular events: MI, stroke, or coronary revascularization, or VTE within 90...
- Participants must not have unstable CVD, defined as a recent clinical cardiovascular event (eg, unstable angina, rapid atrial fibrillation), or a...
- Participants must not have evidence of active cancer or history of cancer (solid organ or hematologic malignancy including myelodysplastic syndrome)...
- Other protocol define inclusion/exclusion criteria apply.
See the full eligibility criteria
- Participants with moderate-to-severe plaque psoriasis:
- Deemed by the Investigator to be a candidate for phototherapy or systemic treatment for psoriasis, including ustekinumab;
- 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...
- 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.
- 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...
- 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...
- Other protocol define inclusion/exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Tempe, Arizona, United States
- Fayetteville, Arkansas, United States
- Rogers, Arkansas, United States
- Encinitas, California, United States
- Encino, California, United States
- Fountain Valley, California, United States
- Fremont, California, United States
- Huntington Beach, California, United States
- Los Angeles, California, United States
- Northridge, California, United States
- Palmdale, California, United States
- Pasadena, California, United States
- Pomona, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Santa Clarita, California, United States
- Santa Monica, California, United States
+ 310 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Tempe, Arizona, United States; Fayetteville, Arkansas, United States; Rogers, Arkansas, United States and 324 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.