Clinical Trials in Italy / NCT07116967
Recruiting
Phase 3
Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
NCT07116967 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Plaque Psoriasis
Investigational drug(s) / intervention(s)
Deucravacitinib: Specified dose on specified days
Ustekinumab: Specified dose on specified days
Study summary
A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
Eligibility
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.
Primary outcome measure(s)
- Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization — Up to 5 years
MACE defined as non-fatal myocardial infarction \[MI\], nonfatal stroke, and cardiovascular death
Trial sites (408)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution - 0088 | Birmingham | Alabama | Not Yet Recruiting |
| Medical Dermatology Specialists - Phoenix | Phoenix | Arizona | Recruiting |
| Saguaro Dermatology - Phoenix | Phoenix | Arizona | Recruiting |
| Omni Dermatology | Phoenix | Arizona | Recruiting |
| Alliance Dermatology | Phoenix | Arizona | Recruiting |
| Local Institution - 0322 | Scottsdale | Arizona | Withdrawn |
| Local Institution - 0188 | Scottsdale | Arizona | Withdrawn |
| Scottsdale Clinical Trials | Scottsdale | Arizona | Recruiting |
| Omni Dermatology | Tempe | Arizona | Recruiting |
| Clinical Trials Institute of Northwest Arkansas | Bentonville | Arkansas | Recruiting |
| Northwest Arkansas Clinical Trials Center (NWACTC), PLLC | Rogers | Arkansas | Recruiting |
| California Dermatology & Clinical Research Institute | Encinitas | California | Recruiting |
| T. Joseph Raoof MD Inc | Encino | California | Recruiting |
| First OC Dermatology - Fountain Valley | Fountain Valley | California | Recruiting |
| Center For Dermatology Clinical Research, Inc. | Fremont | California | Recruiting |
| Marvel Clinical Research | Huntington Beach | California | Recruiting |
| Dermatology Research Associates - Howard Sofen, MD | Los Angeles | California | Recruiting |
| Wallace Skin & Body Institute | Los Angeles | California | Recruiting |
| Northridge Clinical Trials - Elite Clinical Network | Northridge | California | Recruiting |
| Cura Clinical Research - Palmdale | Palmdale | California | Recruiting |
| Pasadena Clinical Trials | Pasadena | California | Recruiting |
| Empire Clinical Research - Pomona | Pomona | California | Recruiting |
| Integrative Skin Science and Research | Sacramento | California | Recruiting |
| UC Davis Dermatology Clinic | Sacramento | California | Recruiting |
| Local Institution - 0078 | San Diego | California | Withdrawn |
| Cura Clinical Research - Santa Clarita | Santa Clarita | California | Recruiting |
| Institute of Clinical Research and Consulting, Inc., d/b/a Clinical Science Institute | Santa Monica | California | Recruiting |
| Advanced Dermatology and Skin Cancer Institute - Beverly Hills | Sherman Oaks | California | Recruiting |
| Unison Clinical Trials | Sherman Oaks | California | Recruiting |
| Golden State Dermatology - Ygnacio Valley Road | Walnut Creek | California | Recruiting |
| Clarity Dermatology PLLC - Castle Rock | Castle Rock | Colorado | Recruiting |
| Local Institution - 0334 | Washington D.C. | District of Columbia | Withdrawn |
| Skin Care Research LLC (SCR) - Boca Raton | Boca Raton | Florida | Recruiting |
| Florida Academic Dermatology Center | Coral Gables | Florida | Recruiting |
| Accel Research Sites - Maitland Clinical Research Unit | Maitland | Florida | Recruiting |
| Driven Research LLC | Miami | Florida | Recruiting |
| Miami Dermatology and Laser Research | Miami | Florida | Recruiting |
| International GCC Research | Miami | Florida | Recruiting |
| BioResearch Partner (BRP) - Miami | Miami | Florida | Recruiting |
| Local Institution - 0029 | Miami Lakes | Florida | Withdrawn |
+ 368 more sites — see the full list on the official registry below.
On this site
📄 Stelara (ustekinumab) drug profile →More Bristol-Myers Squibb trials in Italy
Other trials for the same condition
A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07116967 on ClinicalTrials.gov ↗ ← All trials in Italy