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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:
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

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.