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Purpose

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

Condition

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.