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

Purpose

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

Condition

  • Plaque Psoriasis

Eligibility

Eligible Ages
Over 40 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A
  • Drug: Deucravacitinib
    Specified dose on specified days
    Other names:
    • SOTYKTU
Active Comparator
Arm B
  • Drug: Ustekinumab
    Specified dose on specified days

Recruiting Locations

Medical Dermatology Specialists - Phoenix
Phoenix 5308655, Arizona 5551752 85006-2722
Contact:
Lindsay Ackerman, Site 0107
602-354-5770

Alliance Dermatology
Phoenix 5308655, Arizona 5551752 85032
Contact:
Sasha Jazayeri, Site 0169
602-761-2502

Scottsdale Clinical Trials
Scottsdale 5313457, Arizona 5551752 85260
Contact:
Todd Dreitzler, Site 0432
480-382-7909

Marvel Clinical Research
Huntington Beach 5358705, California 5332921 92647
Contact:
David Rayhan, Site 0176
714-375-5970

Dermatology Research Associates - Howard Sofen, MD
Los Angeles 5368361, California 5332921 90045
Contact:
Howard Sofen, Site 0179
310-337-7171

Northridge Clinical Trials - Elite Clinical Network
Northridge 5377985, California 5332921 91325
Contact:
Navid Ezra, Site 0411
818-350-7483

Pasadena Clinical Trials
Pasadena 5381396, California 5332921 91101
Contact:
Tzu-Jen Tzao, Site 0420
626-822-6554

Clinical Science Institute
Santa Monica 5393212, California 5332921 90404
Contact:
Paul Yamauchi, Site 0306
310-828-8887

Advanced Dermatology and Skin Cancer Institute - Beverly Hills
Sherman Oaks 5395244, California 5332921 91403
Contact:
Michael Lin, Site 0171
661-705-9710

Unison Clinical Trials
Sherman Oaks 5395244, California 5332921 91403
Contact:
Shahram Jacobs, Site 0128
818-981-1555

Skin Care Research LLC (SCR) - Boca Raton
Boca Raton 4148411, Florida 4155751 33486
Contact:
Ann Reed, Site 0164
561-948-3116

Driven Research LLC
Coral Gables 4151871, Florida 4155751 33134
Contact:
Javier Alonso-Llamazares, Site 0070
305-677-2275

Miami Dermatology and Laser Research
Miami 4164138, Florida 4155751 33133
Contact:
Jill Waibel, Site 0313
305-279-6060

International GCC Research
Miami 4164138, Florida 4155751 33135
Contact:
Gilberto Jimenez, Site 0148
786-521-9650

Renstar Medical Research
Ocala 4166673, Florida 4155751 34471
Contact:
Ashley Cauthen, Site 0082
352-629-5800

LENUS Research
Sweetwater 4174600, Florida 4155751 33172
Contact:
John Niven, Site 0124
608-848-8900

Dermatology Affiliates Research Institute
Atlanta 4180439, Georgia 4197000 30305
Contact:
Anita Shetty, Site 0434
404-816-7900

Dawes Fretzin Clinical Research Group, LLC
Indianapolis 4259418, Indiana 4921868 46250
Contact:
Scott Fretzin, Site 0077
317-516-5030

Southern Indiana Clinical trials
New Albany 4262045, Indiana 4921868 47150
Contact:
Megan Landis, Site 0104
812-734-3881

Clinical Trials Management, LLC - Northshore Office
Covington 4321005, Louisiana 4331987 70433
Contact:
Martha Stewart, Site 0449
985-900-2400

Shondra L. Smith, MD - Dermatology and Advanced Aesthetics
Lake Charles 4330236, Louisiana 4331987 70605
Contact:
Shondra Smith, Site 0163
337-477-0010

Clinical Trials Management
Metairie 4333177, Louisiana 4331987 70006
Contact:
Robert Koppel, Site 0166
504-455-1310

Metro Boston Clinical Partners
Brighton 4931353, Massachusetts 6254926 02135
Contact:
Mark Amster, Site 0100
617-783-7100

Las Vegas Clinical Trials, LLC
North Las Vegas 5509403, Nevada 5509151 89030-7193
Contact:
Alton Walters, Site 0396
702-637-3223

Forest Hills Dermatology Group
Kew Gardens 5123344, New York 5128638 11415
Contact:
Jeffrey Weinberg, Site 0028
212-523-3808

Accellacare - Cary
Cary 4459467, North Carolina 4482348 27518
Contact:
Catherine Hren, Site 0076
919-342-3447

Wilmington Dermatology Center-WDC Cosmetic and Research
Wilmington 4499379, North Carolina 4482348 28405
Contact:
Rosalyn George, Site 0189
910-239-5032

Oregon Dermatology and Research Center
Portland 5746545, Oregon 5744337 97210
Contact:
Phoebe Rich, MD, Site 0015
503-226-3376

Best Skin Research
Camp Hill 5182928, Pennsylvania 6254927 17011-2308
Contact:
Stephen Schleicher, Site 0301
717-439-6900

Palmetto Clinical Trial Services - Administrative Office
Anderson 4569298, South Carolina 4597040 29621
Contact:
Theresa Knoepp, Site 0019
864-962-0431

Palmetto Clinical Trial Services - Administrative Office
Greenville 4580543, South Carolina 4597040 29615
Contact:
Matthew Miller, Site 0190
864-962-0431

Studies in Dermatology, LLC
Cypress 4684724, Texas 4736286 77429
Contact:
Lauren Campbell, Site 0178
346-818-5204

Modern Research Associates, PLLC
Dallas 4684888, Texas 4736286 75231
Contact:
Jennifer Cather, Site 0086
214-361-2008

Texas Dermatology and Laser Specialists
San Antonio 4726206, Texas 4736286 78218
Contact:
John Browning, Site 0083
210-704-4037

Center For Clinical Studies
Webster 4740423, Texas 4736286 77598
Contact:
Stephen Tyring, Site 0381
713-528-8818

Premier Clinical Research
Spokane 5811696, Washington 5815135 99202
Contact:
William Werschler, Site 0175
509-343-3710

Centro Reumatologico Caguas
Caguas 4563008, Puerto Rico 00725
Contact:
AMARILIS PEREZ DE JESUS, Site 0475
7872868465

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
8559073286
Clinical.Trials@bms.com