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:
Margaret Kessler, Site 0107
602-354-5770

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

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

T. Joseph Raoof MD Inc
Encino 5346649, California 5332921 91436
Contact:
TOORAJ RAOOF, Site 0149
818-788-5060

Center For Dermatology Clinical Research, Inc.
Fremont 5350734, California 5332921 94538
Contact:
Sunil Dhawan, Site 0087
510-797-0140

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

Cura Clinical Research - Palmdale
Palmdale 5380698, California 5332921 93551
Contact:
Aram Kechichian, Site 0426
833-525-2872

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

Empire Clinical Research - Pomona
Pomona 5384170, California 5332921 91767
Contact:
Radhika Shah, Site 0387
909-981-5321

Cura Clinical Research - Santa Clarita
Santa Clarita 5393049, California 5332921 91355
Contact:
Bernard Raskin, Site 0427
833-525-2872

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

Accel Research Sites - Maitland Clinical Research Unit
Maitland 4163220, Florida 4155751 32751
Contact:
Eva-Maria Heurich, Site 0478
407-426-9299

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

Endeavor Health Clinical Trials
Skokie 4911600, Illinois 4896861 60077
Contact:
Stephanie Mehlis, Site 0138
847-663-8530

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

Equity Medical - Bowling Green
Bowling Green 4285268, Kentucky 6254925 42104
Contact:
David Johnson, Site 0435

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

Michigan Center for Skin Care Research
Clinton Township 4989133, Michigan 5001836 48038-1137
Contact:
Mary Veremis-Ley, Site 0329
586-286-7325

Somerset Skin Centre
Troy 5012639, Michigan 5001836 48084-5260
Contact:
George Murakawa, Site 0145
248-244-8448

Minnesota Clinical Study Center (MCSC)
New Brighton 5039080, Minnesota 5037779 55112
Contact:
Steven Kempers, Site 0033
763-571-7202

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

StracSkin
Portsmouth 5091383, New Hampshire 5090174 03801
Contact:
Abel Jarell, Site 0460
603-319-7625

Schweiger Dermatology
Verona 5105809, New Jersey 5101760 07044
Contact:
Avnee Shah, Site 0359
929-547-0508

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

Skin Search Rochester
Rochester 5134086, New York 5128638 14623-1507
Contact:
John Tu, Site 0010
585-697-1818

Equity Medical - New York
The Bronx 5110266, New York 5128638 10455
Contact:
Maira Fonseca, Site 0437

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

Hickory Dermatology Research Center
Hickory 4470778, North Carolina 4482348 28602
Contact:
Jake Turrentine, Site 0406
828-638-4626

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

Apex Clinical Research Center - Canton
Canton 5149222, Ohio 5165418 44718
Contact:
Jorge García-Zuazaga, Site 0492
440-940-2739

Apex Clinical Research Center
Mayfield Heights 5162188, Ohio 5165418 44124
Contact:
Jorge García-Zuazaga, Site 0253
440-352-7546

Unity Clinical Research (UCR)
Oklahoma City 4544349, Oklahoma 4544379 73118-2864
Contact:
Robert Westcott, Site 0110
405-606-3900

Velocity Clinical Research, Medford
Medford 5740099, Oregon 5744337 97504
Contact:
Sarah Smiley, Site 0394
541-858-1018

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

UPMC Department of Dermatology
Pittsburgh 5206379, Pennsylvania 6254927 15213
Contact:
Joe Tung, Site 0095
412-647-2013

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

Discover Dermatology, LLC d/b/a Goodlettsville Dermatology Research
Goodlettsville 4625282, Tennessee 4662168 37072-2301
Contact:
Keith Loven, Site 0407
615-241-2820

Cumberland Skin Center for Clinical Research
Hermitage 4628929, Tennessee 4662168 37076
Contact:
Judy Hu, Site 0338
615-829-6980

International Clinical Research (IC Research) - Murfreesboro
Murfreesboro 4644312, Tennessee 4662168 37130
Contact:
Christina Feser, Site 0336
615-410-3460

Belle Meade Dermatology Research
Nashville 4644585, Tennessee 4662168 37205
Contact:
Ashley Matthews, Site 0408
615-216-5893

Arlington Center for Dermatology
Arlington 4671240, Texas 4736286 76011
Contact:
Angela Moore, Site 0057
817-795-7546

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

Frontier Dermatology
Mill Creek 5803457, Washington 5815135 98012
Contact:
Ein Gun Song, Site 0186
425-275-4404

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
855-907-3286
Clinical.Trials@bms.com