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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 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

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.