Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
a study on Psoriasis
Summary
- Eligibility
- for people ages 40 years and up (full criteria)
- Location
- at UC Davis
- Dates
- study startedstudy ends around
Description
Summary
A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
Official Title
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
Keywords
Plaque Psoriasis, Deucravacitinib, Cardiovascular risk, PRAGMATYK, Ustekinumab
Eligibility
You can join if…
Open to people ages 40 years and up
- 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 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.
You 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 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.
Locations
- UC Davis Dermatology Clinic
accepting new patients
Sacramento California 95816 United States - Institute of Clinical Research and Consulting, Inc., d/b/a Clinical Science Institute
accepting new patients
Santa Monica California 90403 United States - Advanced Dermatology and Skin Cancer Institute - Beverly Hills
accepting new patients
Sherman Oaks California 91403 United States - Unison Clinical Trials
accepting new patients
Sherman Oaks California 91403 United States - T. Joseph Raoof MD Inc
accepting new patients
Encino California 91436 United States - Dermatology Research Associates - Howard Sofen, MD
accepting new patients
Los Angeles California 90045 United States - First OC Dermatology - Fountain Valley
accepting new patients
Fountain Valley California 92708 United States - Wallace Skin & Body Institute
accepting new patients
Los Angeles California 90056-1660 United States - Local Institution - 0078
withdrawn
San Diego California 92123-1523 United States - Marvel Clinical Research
accepting new patients
Huntington Beach California 92647 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Bristol-Myers Squibb
- ID
- NCT07116967
- Phase
- Phase 3 Psoriasis Research Study
- Study Type
- Interventional
- Participants
- Expecting 3040 study participants
- Last Updated
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study, which might include an external sponsor. Providing your contact details does not obligate you to participate in the research.
Thank you!
The study team should get back to you in a few business days.