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, Arizona 85006-2722
Contact:
Margaret Kessler, Site 0107
602-354-5770

Saguaro Dermatology - Phoenix
Phoenix, Arizona 85008
Contact:
Dathan Hamann, Site 0495

Omni Dermatology
Phoenix, Arizona 85018
Contact:
Andrew Racette, Site 0496
800-774-1534 EXT 1

Alliance Dermatology
Phoenix, Arizona 85032
Contact:
Sadra Jazayeri, Site 0169
602-761-2502

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

Omni Dermatology
Tempe, Arizona 85282
Contact:
Jeffrey Dickman, Site 0501

Clinical Trials Institute of Northwest Arkansas
Fayetteville, Arkansas 72703-6245
Contact:
Mildred Clifton, Site 0335

Northwest Arkansas Clinical Trials Center (NWACTC), PLLC
Rogers, Arkansas 72758
Contact:
Cheryl Hull, Site 0135
479-254-9652

California Dermatology & Clinical Research Institute
Encinitas, California 92024-7700
Contact:
Stacy Smith, Site 0187
8585716800x114

T. Joseph Raoof MD Inc
Encino, California 91436
Contact:
TOORAJ RAOOF, Site 0149
818-788-5060

Center For Dermatology Clinical Research, Inc.
Fremont, California 94538
Contact:
Sunil Dhawan, Site 0087
510-797-0140

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

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

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

Cura Clinical Research - Palmdale
Palmdale, California 93551
Contact:
Aram Kechichian, Site 0426
833-525-2872

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

Empire Clinical Research - Pomona
Pomona, California 91767
Contact:
Radhika Shah, Site 0387
909-981-5321

Integrative Skin Science and Research
Sacramento, California 95815
Contact:
Raja Sivamani, Site 0316
510-847-6713

Cura Clinical Research - Santa Clarita
Santa Clarita, California 91355
Contact:
Bernard Raskin, Site 0427
833-525-2872

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

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

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

Golden State Dermatology - Ygnacio Valley Road
Walnut Creek, California 94598-3335
Contact:
Michael Wang, Site 0181
507-261-3758

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

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

Florida Academic Dermatology Center
Coral Gables, Florida 33134
Contact:
Francisco Kerdel, Site 0105
305-324-2110

Accel Research Sites - Maitland Clinical Research Unit
Maitland, Florida 32751
Contact:
Eva-Maria Heurich, Site 0478
407-426-9299

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

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

BioResearch Partner (BRP) - Miami
Miami, Florida 33155
Contact:
Oscar Hevia, Site 0493

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

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

Hamilton Dermatology (Atlanta Dermatology, Vein & Research Center, LLC)
Alpharetta, Georgia 30022
Contact:
Tiffani Hamilton, Site 0304
770-255-2533

Velocity Clinical Research, Savannah
Savannah, Georgia 31406
Contact:
Paul Bradley, Site 0419
402-933-6501

Endeavor Health Clinical Trials
Skokie, Illinois 60077
Contact:
Stephanie Mehlis, Site 0138
847-663-8530

Deaconess Clinic Downtown
Evansville, Indiana 47708
Contact:
Jamie Mull, Site 0168
812-858-4508

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

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

Equity Medical - Bowling Green
Bowling Green, Kentucky 42104
Contact:
David Johnson, Site 0435

Physician Skin Care, PLLC
Louisville, Kentucky 40217
Contact:
Leon Kircik, Site 0096
502-451-9000

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

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

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

Lawrence J. Green, MD. LLC
Rockville, Maryland 20850
Contact:
Lawrence Green, Site 0314
301-610-0663

U.S. Dermatology Partners Rockville
Rockville, Maryland 20850
Contact:
Benjamin Lockshin, Site 0331
301-355-3183

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

Kuchnir Dermatology & Dermatologic Surgery
Milford, Massachusetts 01757
Contact:
Shiu-Chung Au, Site 0409
508-251-9150

Oakland Hills Dermatology
Auburn Hills, Michigan 48326-3396
Contact:
Christofer Buatti, Site 0090
248-858-2255

Michigan Center for Skin Care Research
Clinton Township, Michigan 48038-1137
Contact:
Mary Veremis-Ley, Site 0329
586-286-7325

Somerset Skin Centre
Troy, Michigan 48084-5260
Contact:
George Murakawa, Site 0145
248-244-8448

Minnesota Clinical Study Center (MCSC)
New Brighton, Minnesota 55112
Contact:
Steven Kempers, Site 0033
763-571-7202

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

StracSkin
Portsmouth, New Hampshire 03801
Contact:
Abel Jarell, Site 0460
603-319-7625

Forest Hills Dermatology Group
Kew Gardens, New York 11415
Contact:
Jeffrey Weinberg, Site 0028

The Skin Center Dermatology Group
New City, New York 10956-7153
Contact:
Peter Friedman, Site 0393
845-352-0500

Skin Search Rochester
Rochester, New York 14623-1507
Contact:
John Tu, Site 0010
585-697-1818

Elyse S. Rafal, MD PC - Rafal Center for Dermatology & Cosmetic Surgery
Stony Brook, New York 11790-2598
Contact:
Elyse Rafal, Site 0170
631-880-9660

Equity Medical - New York
The Bronx, New York 10455
Contact:
Maira Fonseca, Site 0437

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

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

Apex Clinical Research Center - Canton
Canton, Ohio 44718
Contact:
Jorge García-Zuazaga, Site 0492
440-940-2739

Wright State Physicians
Fairborn, Ohio 45324
Contact:
Craig Rohan, Site 0182
937-245-7922

Dermatologists of Southwest Ohio
Mason, Ohio 45040
Contact:
Rocco Serrao, Site 0183
513-701-5526

Apex Clinical Research Center
Mayfield Heights, Ohio 44124
Contact:
Jorge García-Zuazaga, Site 0253
440-352-7546

Dermatology Partners Inc. - Medina Clinical Research
Medina, Ohio 44256-9312
Contact:
Justin Hastings, Site 0436
330-952-2040

Unity Clinical Research (UCR)
Oklahoma City, Oklahoma 73118-2864
Contact:
Robert Westcott, Site 0110
405-606-3900

Central Sooner Research (CSR) - Oklahoma City
Oklahoma City, Oklahoma 73170
Contact:
Yaohan Lam, Site 0167
405-724-7341

Velocity Clinical Research, Medford
Medford, Oregon 97504
Contact:
Sarah Smiley, Site 0394
541-858-1018

Oregon Medical Research Center
Portland, Oregon 97201
Contact:
Benjamin Ehst, Site 0180
503-245-1525

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

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

UPMC Department of Dermatology
Pittsburgh, Pennsylvania 15213
Contact:
Joe Tung, Site 0095
412-647-2013

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

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

International Clinical Research (IC Research) - Murfreesboro
Murfreesboro, Tennessee 37130
Contact:
Christina Feser, Site 0336
615-410-3460

Arlington Center for Dermatology
Arlington, Texas 76011
Contact:
Angela Moore, Site 0057
817-795-7546

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

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

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

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

Frontier Dermatology
Mill Creek, Washington 98012
Contact:
Ein Gun Song, Site 0186
425-275-4404

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

Centro Reumatologico Caguas
Caguas, 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
855-907-3286
Clinical.Trials@bms.com