RECRUITING

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

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Conditions

Plaque PsoriasisDeucravacitinibCardiovascular riskPRAGMATYK

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-10-30
Study Completion:2031-01-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07116967

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants with moderate-to-severe plaque psoriasis:
  2. 1. Deemed by the Investigator to be a candidate for phototherapy or systemic treatment for psoriasis, including ustekinumab;
  3. 2. Have at least 1 of the following cardiovascular risk factors:
  4. * Current cigarette smoker
  5. * Diagnosis of hypertension
  6. * Diagnosis of hyperlipidemia
  7. * Diabetes mellitus type 1 or 2
  8. * 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
  9. * Obesity
  10. * 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.
  1. * 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.
  2. * 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.
  3. * 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).
  4. * Other protocol define inclusion/exclusion criteria apply.

Contacts and Locations

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
8559073286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0088
Birmingham, Alabama, 35249
United States
Local Institution - 0107
Phoenix, Arizona, 85006-2722
United States
Local Institution - 0169
Phoenix, Arizona, 85032
United States
Local Institution - 0322
Scottsdale, Arizona, 85254
United States
Local Institution - 0188
Scottsdale, Arizona, 85255
United States
Local Institution - 0432
Scottsdale, Arizona, 85260
United States
Local Institution - 0335
Fayetteville, Arkansas, 72703-6245
United States
Dermatology Research Associates - Howard Sofen, MD
Los Angeles, California, 90045
United States
Local Institution - 0192
Los Angeles, California, 90056-1660
United States
Local Institution - 0411
Northridge, California, 91325
United States
Local Institution - 0426
Palmdale, California, 93551
United States
Local Institution - 0420
Pasadena, California, 91101
United States
Local Institution - 0387
Pomona, California, 91767
United States
Local Institution - 0316
Sacramento, California, 95815
United States
Local Institution - 0038
Sacramento, California, 95816
United States
Local Institution - 0078
San Diego, California, 92123-1523
United States
Local Institution - 0427
Santa Clarita, California, 91355
United States
Local Institution - 0181
Walnut Creek, California, 94598-3335
United States
Local Institution - 0334
Washington D.C., District of Columbia, 20746
United States
Local Institution - 0105
Coral Gables, Florida, 33134
United States
Local Institution - 0478
Maitland, Florida, 32751
United States
Local Institution - 0148
Miami, Florida, 33135
United States
Local Institution - 0029
Miami Lakes, Florida, 33014
United States
Local Institution - 0089
Tampa, Florida, 33615
United States
Local Institution - 0434
Atlanta, Georgia, 30305-2515
United States
Local Institution - 0419
Savannah, Georgia, 31406
United States
Local Institution - 0395
Chicago, Illinois, 60614
United States
Local Institution - 0138
Skokie, Illinois, 60077-1049
United States
Local Institution - 0077
Indianapolis, Indiana, 46256
United States
Local Institution - 0435
Bowling Green, Kentucky, 42104
United States
Local Institution - 0030
Owensboro, Kentucky, 42301
United States
Local Institution - 0449
Covington, Louisiana, 70433
United States
Shondra L. Smith, MD - Dermatology and Advanced Aesthetics
Lake Charles, Louisiana, 70605
United States
Clinical Trials Management
Metairie, Louisiana, 70006
United States
Local Institution - 0069
New Orleans, Louisiana, 70112
United States
Local Institution - 0331
Rockville, Maryland, 20850
United States
Local Institution - 0100
Brighton, Massachusetts, 02135-3511
United States
Local Institution - 0409
Milford, Massachusetts, 01757
United States
Local Institution - 0287
Quincy, Massachusetts, 02169-4339
United States
Local Institution - 0329
Clinton Township, Michigan, 48038-1137
United States
Local Institution - 0433
Columbia, Missouri, 65201-6625
United States
Local Institution - 0397
Omaha, Nebraska, 68114-2508
United States
Local Institution - 0454
Las Vegas, Nevada, 89145
United States
Local Institution - 0396
North Las Vegas, Nevada, 89030-7193
United States
Local Institution - 0097
Portsmouth, New Hampshire, 03801
United States
Local Institution - 0079
Teaneck, New Jersey, 07666
United States
Local Institution - 0359
Verona, New Jersey, 07044
United States
Local Institution - 0028
Kew Gardens, New York, 11415
United States
Local Institution - 0393
New City, New York, 10956-7153
United States
Local Institution - 0437
New York, New York, 10023
United States
Local Institution - 0410
New York, New York, 10029-6574
United States
Local Institution - 0076
Cary, North Carolina, 27518
United States
Local Institution - 0332
Chapel Hill, North Carolina, 27516
United States
Local Institution - 0165
Chapel Hill, North Carolina, 27517
United States
Local Institution - 0406
Hickory, North Carolina, 28602-1469
United States
Local Institution - 0189
Wilmington, North Carolina, 28405
United States
Local Institution - 0177
Bexley, Ohio, 43209-2421
United States
Local Institution - 0392
Canal Winchester, Ohio, 43110-2069
United States
Local Institution - 0492
Canton, Ohio, 44716
United States
Local Institution - 0436
Medina, Ohio, 44256-9312
United States
Local Institution - 0394
Medford, Oregon, 97504-7738
United States
Local Institution - 0301
Camp Hill, Pennsylvania, 17011-2308
United States
Local Institution - 0131
Exton, Pennsylvania, 19341
United States
Local Institution - 0095
Pittsburgh, Pennsylvania, 15238
United States
Local Institution - 0422
Greenville, South Carolina, 29615
United States
Local Institution - 0418
North Charleston, South Carolina, 29405
United States
Local Institution - 0084
Rapid City, South Dakota, 57702-9208
United States
Local Institution - 0407
Goodlettsville, Tennessee, 37072-2301
United States
Local Institution - 0408
Nashville, Tennessee, 37205-1565
United States
Local Institution - 0057
Arlington, Texas, 76011
United States
Studies in Dermatology, LLC
Cypress, Texas, 77429
United States
Local Institution - 0468
Dallas, Texas, 75390
United States
Local Institution - 0381
Houston, Texas, 77004
United States
Local Institution - 0083
San Antonio, Texas, 78218
United States
Local Institution - 0333
Norfolk, Virginia, 23502
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-10-30
Study Completion Date2031-01-16

Study Record Updates

Study Start Date2025-10-30
Study Completion Date2031-01-16

Terms related to this study

Keywords Provided by Researchers

  • Deucravacitinib
  • Plaque psoriasis
  • Cardiovascular risk
  • PRAGMATYK

Additional Relevant MeSH Terms

  • Plaque Psoriasis