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

Recruiting · NCT07116967 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb

View the official record on ClinicalTrials.gov →

Psoriasis

Interventions studied

Deucravacitinib Ustekinumab

What this trial is about

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

Who can take part

Age range

40 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

Inclusion 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 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.

Where it is running

60 locations listed across 33 US states.

Local Institution - 0088 - Birmingham, Alabama, United States
Medical Dermatology Specialists - Phoenix - Phoenix, Arizona, United States
Saguaro Dermatology - Phoenix - Phoenix, Arizona, United States
Omni Dermatology - Phoenix, Arizona, United States
Alliance Dermatology - Phoenix, Arizona, United States
Local Institution - 0322 - Scottsdale, Arizona, United States
Local Institution - 0188 - Scottsdale, Arizona, United States
Scottsdale Clinical Trials - Scottsdale, Arizona, United States
Omni Dermatology - Tempe, Arizona, United States
Clinical Trials Institute of Northwest Arkansas - Fayetteville, Arkansas, United States
Northwest Arkansas Clinical Trials Center (NWACTC), PLLC - Rogers, Arkansas, United States
California Dermatology & Clinical Research Institute - Encinitas, California, United States
T. Joseph Raoof MD Inc - Encino, California, United States
First OC Dermatology - Fountain Valley - Fountain Valley, California, United States
Center For Dermatology Clinical Research, Inc. - Fremont, California, United States
Marvel Clinical Research - Huntington Beach, California, United States
Dermatology Research Associates - Howard Sofen, MD - Los Angeles, California, United States
Wallace Skin & Body Institute - Los Angeles, California, United States
Northridge Clinical Trials - Elite Clinical Network - Northridge, California, United States
Cura Clinical Research - Palmdale - Palmdale, California, United States
Pasadena Clinical Trials - Pasadena, California, United States
Empire Clinical Research - Pomona - Pomona, California, United States
Integrative Skin Science and Research - Sacramento, California, United States
UC Davis Dermatology Clinic - Sacramento, California, United States
Local Institution - 0078 - San Diego, California, United States
Cura Clinical Research - Santa Clarita - Santa Clarita, California, United States
Institute of Clinical Research and Consulting, Inc., d/b/a Clinical Science Institute - Santa Monica, California, United States
Advanced Dermatology and Skin Cancer Institute - Beverly Hills - Sherman Oaks, California, United States
Unison Clinical Trials - Sherman Oaks, California, United States
Golden State Dermatology - Ygnacio Valley Road - Walnut Creek, California, United States
Clarity Dermatology PLLC - Castle Rock - Castle Rock, Colorado, United States
Local Institution - 0334 - Washington D.C., District of Columbia, United States
Skin Care Research LLC (SCR) - Boca Raton - Boca Raton, Florida, United States
Florida Academic Dermatology Center - Coral Gables, Florida, United States
Accel Research Sites - Maitland Clinical Research Unit - Maitland, Florida, United States
Driven Research LLC - Miami, Florida, United States
Miami Dermatology and Laser Research - Miami, Florida, United States
International GCC Research - Miami, Florida, United States
BioResearch Partner (BRP) - Miami - Miami, Florida, United States
Local Institution - 0029 - Miami Lakes, Florida, United States
Renstar Medical Research - Ocala, Florida, United States
LENUS Research - Sweetwater, Florida, United States
Local Institution - 0089 - Tampa, Florida, United States
Hamilton Dermatology (Atlanta Dermatology, Vein & Research Center, LLC) - Alpharetta, Georgia, United States
Local Institution - 0434 - Atlanta, Georgia, United States
Velocity Clinical Research, Savannah - Savannah, Georgia, United States
Local Institution - 0395 - Chicago, Illinois, United States
Endeavor Health Clinical Trials - Skokie, Illinois, United States
Deaconess Clinic Downtown - Evansville, Indiana, United States
Dawes Fretzin Clinical Research Group, LLC - Indianapolis, Indiana, United States
Southern Indiana Clinical trials - New Albany, Indiana, United States
Equity Medical - Bowling Green - Bowling Green, Kentucky, United States
Physician Skin Care, PLLC - Louisville, Kentucky, United States
Local Institution - 0030 - Owensboro, Kentucky, United States
Clinical Trials Management, LLC - Northshore Office - Covington, Louisiana, United States
Shondra L. Smith, MD - Dermatology and Advanced Aesthetics - Lake Charles, Louisiana, United States
Clinical Trials Management - Metairie, Louisiana, United States
Tulane University School of Medicine - Tulane Dermatology & Multispecialty Clinic - New Orleans, Louisiana, United States
Lawrence J. Green, MD. LLC - Rockville, Maryland, United States
U.S. Dermatology Partners Rockville - Rockville, Maryland, United States

Showing 60 of 402 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →