Recruiting
Phase 3

Deucravacitinib vs. Ustekinumab

Sponsor:

Bristol-Myers Squibb

Code:

NCT07116967

Conditions

Plaque Psoriasis

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Deucravacitinib

Ustekinumab

Study Details

Brief summary:

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

Conditions

Plaque Psoriasis

Study ID

NCT07116967

Start date

Sep 22, 2025

Status verified date

Sep, 2026

Completion date

Jan 16, 2031

Anticipated

Primary completion date

Jan 16, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Enrollment

3040 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

active comparator: Arm B

Interventions

Deucravacitinib

Specified dose on specified days

Ustekinumab

Specified dose on specified days

Primary outcome measure

  • Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

Medical Dermatology Specialists - Phoenix

Recruiting

Phoenix, Arizona, United States, 85006-2722

Contacts

Margaret Kessler, Site 0107

602-354-5770

Saguaro Dermatology - Phoenix

Recruiting

Phoenix, Arizona, United States, 85008

Omni Dermatology

Recruiting

Phoenix, Arizona, United States, 85018

Alliance Dermatology

Recruiting

Phoenix, Arizona, United States, 85032

Contacts

Sadra Jazayeri, Site 0169

602-761-2502

Scottsdale Clinical Trials

Recruiting

Scottsdale, Arizona, United States, 85260

Contacts

Todd Dreitzler, Site 0432

480-382-7909

Omni Dermatology

Recruiting

Tempe, Arizona, United States, 85282

Clinical Trials Institute of Northwest Arkansas

Recruiting

Bentonville, Arkansas, United States, 72712

Northwest Arkansas Clinical Trials Center (NWACTC), PLLC

Recruiting

Rogers, Arkansas, United States, 72758

Contacts

Cheryl Hull, Site 0135

479-254-9652

California Dermatology & Clinical Research Institute

Recruiting

Encinitas, California, United States, 92024

Contacts

Stacy Smith, Site 0187

8585716800x114

T. Joseph Raoof MD Inc

Recruiting

Encino, California, United States, 91436

Contacts

TOORAJ RAOOF, Site 0149

818-788-5060

First OC Dermatology - Fountain Valley

Recruiting

Fountain Valley, California, United States, 92708

Contacts

Vivian Laquer, Site 0132

714-531-2966

Center For Dermatology Clinical Research, Inc.

Recruiting

Fremont, California, United States, 94538

Contacts

Sunil Dhawan, Site 0087

510-797-0140

Marvel Clinical Research

Recruiting

Huntington Beach, California, United States, 92647

Contacts

David Rayhan, Site 0176

714-375-5970

Dermatology Research Associates - Howard Sofen, MD

Recruiting

Los Angeles, California, United States, 90045

Contacts

Howard Sofen, Site 0179

310-337-7171

Wallace Skin & Body Institute

Recruiting

Los Angeles, California, United States, 90056-1660

Contacts

Paul Wallace, Site 0192

213-699-9444

Northridge Clinical Trials - Elite Clinical Network

Recruiting

Northridge, California, United States, 91325

Contacts

Navid Ezra, Site 0411

818-350-7483

Cura Clinical Research - Palmdale

Recruiting

Palmdale, California, United States, 93551

Contacts

Aram Kechichian, Site 0426

833-525-2872

Pasadena Clinical Trials

Recruiting

Pasadena, California, United States, 91101

Contacts

Tzu-Jen Tzao, Site 0420

626-822-6554

Empire Clinical Research - Pomona

Recruiting

Pomona, California, United States, 91767

Contacts

Radhika Shah, Site 0387

909-981-5321

Integrative Skin Science and Research

Recruiting

Sacramento, California, United States, 95815

Contacts

Raja Sivamani, Site 0316

510-847-6713

UC Davis Dermatology Clinic

Recruiting

Sacramento, California, United States, 95816

Contacts

Emanual Maverakis, Site 0038

916-734-8254

Cura Clinical Research - Santa Clarita

Recruiting

Santa Clarita, California, United States, 91355

Contacts

Bernard Raskin, Site 0427

833-525-2872

Institute of Clinical Research and Consulting, Inc., d/b/a Clinical Science Institute

Recruiting

Santa Monica, California, United States, 90403

Contacts

Paul Yamauchi, Site 0306

310-828-8887

Advanced Dermatology and Skin Cancer Institute - Beverly Hills

Recruiting

Sherman Oaks, California, United States, 91403

Contacts

Michael Lin, Site 0171

661-705-9710

Unison Clinical Trials

Recruiting

Sherman Oaks, California, United States, 91403

Contacts

Shahram Jacobs, Site 0128

818-981-1555

Golden State Dermatology - Ygnacio Valley Road

Recruiting

Walnut Creek, California, United States, 94598-3335

Contacts

Michael Wang, Site 0181

507-261-3758

Clarity Dermatology PLLC - Castle Rock

Recruiting

Castle Rock, Colorado, United States, 80109

Skin Care Research LLC (SCR) - Boca Raton

Recruiting

Boca Raton, Florida, United States, 33486

Contacts

Ann Reed, Site 0164

561-948-3116

Florida Academic Dermatology Center

Recruiting

Coral Gables, Florida, United States, 33134

Contacts

Francisco Kerdel, Site 0105

305-324-2110

Accel Research Sites - Maitland Clinical Research Unit

Recruiting

Maitland, Florida, United States, 32751

Driven Research LLC

Recruiting

Miami, Florida, United States, 33126

Contacts

Javier Alonso-Llamazares, Site 0070

305-677-2275

Miami Dermatology and Laser Research

Recruiting

Miami, Florida, United States, 33133

Contacts

Jill Waibel, Site 0313

305-279-6060

International GCC Research

Recruiting

Miami, Florida, United States, 33135

Contacts

Gilberto Jimenez, Site 0148

786-521-9650

BioResearch Partner (BRP) - Miami

Recruiting

Miami, Florida, United States, 33155

Renstar Medical Research

Recruiting

Ocala, Florida, United States, 34471

Contacts

Ashley Cauthen, Site 0082

352-629-5800

LENUS Research

Recruiting

Sweetwater, Florida, United States, 33172

Contacts

John Niven, Site 0124

608-848-8900

Hamilton Dermatology (Atlanta Dermatology, Vein & Research Center, LLC)

Recruiting

Alpharetta, Georgia, United States, 30022

Contacts

Tiffani Hamilton, Site 0304

770-255-2533

Velocity Clinical Research, Savannah

Recruiting

Savannah, Georgia, United States, 31406

Contacts

Paul Bradley, Site 0419

402-933-6501

Endeavor Health Clinical Trials

Recruiting

Skokie, Illinois, United States, 60077

Contacts

Stephanie Mehlis, Site 0138

847-663-8530

Deaconess Clinic Downtown

Recruiting

Evansville, Indiana, United States, 47708

Contacts

Jamie Mull, Site 0168

812-858-4508

Dawes Fretzin Clinical Research Group, LLC

Recruiting

Indianapolis, Indiana, United States, 46250

Contacts

Scott Fretzin, Site 0077

317-516-5030

Southern Indiana Clinical trials

Recruiting

New Albany, Indiana, United States, 47150

Contacts

Megan Landis, Site 0104

812-734-3881

Equity Medical - Bowling Green

Recruiting

Bowling Green, Kentucky, United States, 42104

Physician Skin Care, PLLC

Recruiting

Louisville, Kentucky, United States, 40217

Contacts

Leon Kircik, Site 0096

502-451-9000

Clinical Trials Management, LLC - Northshore Office

Recruiting

Covington, Louisiana, United States, 70433

Contacts

Martha Stewart, Site 0449

985-900-2400

Shondra L. Smith, MD - Dermatology and Advanced Aesthetics

Recruiting

Lake Charles, Louisiana, United States, 70605

Contacts

Shondra Smith, Site 0163

337-477-0010

Clinical Trials Management

Recruiting

Metairie, Louisiana, United States, 70006

Contacts

Robert Koppel, Site 0166

504-455-1310

Tulane University School of Medicine - Tulane Dermatology & Multispecialty Clinic

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Erin Boh, Site 0069

504-988-5114

Lawrence J. Green, MD. LLC

Recruiting

Rockville, Maryland, United States, 20850

Contacts

Lawrence Green, Site 0314

301-610-0663

U.S. Dermatology Partners Rockville

Recruiting

Rockville, Maryland, United States, 20850

Contacts

Benjamin Lockshin, Site 0331

301-355-3183

Metro Boston Clinical Partners

Recruiting

Brighton, Massachusetts, United States, 02135

Contacts

Mark Amster, Site 0100

617-783-7100

Kuchnir Dermatology & Dermatologic Surgery

Recruiting

Milford, Massachusetts, United States, 01757

Contacts

Shiu-Chung Au, Site 0409

508-251-9150

Oakland Hills Dermatology

Recruiting

Auburn Hills, Michigan, United States, 48326-3396

Contacts

Christofer Buatti, Site 0090

248-858-2255

Michigan Center for Skin Care Research

Recruiting

Clinton Township, Michigan, United States, 48038-1137

Contacts

Mary Veremis-Ley, Site 0329

586-286-7325

Somerset Skin Centre

Recruiting

Troy, Michigan, United States, 48084-5260

Contacts

George Murakawa, Site 0145

248-244-8448

Michigan Dermatology Institute - Waterford

Recruiting

Waterford, Michigan, United States, 48328-3277

Minnesota Clinical Study Center (MCSC)

Recruiting

New Brighton, Minnesota, United States, 55112

Contacts

Steven Kempers, Site 0033

763-571-7202

Saint Louis University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Maria Hurley, Site 0298

800-758-3678

Las Vegas Clinical Trials, LLC

Recruiting

North Las Vegas, Nevada, United States, 89030-7193

Contacts

Alton Walters, Site 0396

702-637-3223

StracSkin

Recruiting

Portsmouth, New Hampshire, United States, 03801

Contacts

Abel Jarell, Site 0460

603-319-7625

Forest Hills Dermatology Group

Recruiting

Kew Gardens, New York, United States, 11415

The Skin Center Dermatology Group

Recruiting

New City, New York, United States, 10956-7153

Contacts

Peter Friedman, Site 0393

845-352-0500

Skin Search Rochester

Recruiting

Rochester, New York, United States, 14623-1507

Contacts

John Tu, Site 0010

585-697-1818

Elyse S. Rafal, MD PC - Rafal Center for Dermatology & Cosmetic Surgery

Recruiting

Stony Brook, New York, United States, 11790-2598

Contacts

Elyse Rafal, Site 0170

631-880-9660

Equity Medical - New York

Recruiting

The Bronx, New York, United States, 10455

Accellacare - Cary

Recruiting

Cary, North Carolina, United States, 27518

Contacts

Catherine Hren, Site 0076

919-342-3447

Wilmington Dermatology Center-WDC Cosmetic and Research

Recruiting

Wilmington, North Carolina, United States, 28405

Contacts

Rosalyn George, Site 0189

910-239-5032

Apex Clinical Research Center - Canton

Recruiting

Canton, Ohio, United States, 44718

Contacts

Jorge García-Zuazaga, Site 0492

440-940-2739

Wright State Physicians

Recruiting

Fairborn, Ohio, United States, 45324

Contacts

Craig Rohan, Site 0182

937-245-7922

Dermatologists of Southwest Ohio

Recruiting

Mason, Ohio, United States, 45040

Contacts

Rocco Serrao, Site 0183

513-701-5526

Apex Clinical Research Center

Recruiting

Mayfield Heights, Ohio, United States, 44124

Contacts

Jorge García-Zuazaga, Site 0253

440-352-7546

Dermatology Partners Inc. - Medina Clinical Research

Recruiting

Medina, Ohio, United States, 44256-9312

Contacts

Justin Hastings, Site 0436

330-952-2040

Unity Clinical Research (UCR)

Recruiting

Oklahoma City, Oklahoma, United States, 73118-2864

Contacts

Robert Westcott, Site 0110

405-606-3900

Central Sooner Research (CSR) - Oklahoma City

Recruiting

Oklahoma City, Oklahoma, United States, 73170

Contacts

Yaohan Lam, Site 0167

405-724-7341

Velocity Clinical Research, Medford

Recruiting

Medford, Oregon, United States, 97504

Contacts

Sarah Smiley, Site 0394

541-858-1018

Oregon Medical Research Center

Recruiting

Portland, Oregon, United States, 97201

Contacts

Benjamin Ehst, Site 0180

503-245-1525

Oregon Dermatology and Research Center

Recruiting

Portland, Oregon, United States, 97210

Contacts

Phoebe Rich, MD, Site 0015

503-226-3376

Best Skin Research

Recruiting

Camp Hill, Pennsylvania, United States, 17011-2308

Contacts

Stephen Schleicher, Site 0301

717-439-6900

UPMC Department of Dermatology

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Joe Tung, Site 0095

412-647-2013

Palmetto Clinical Trial Services - Administrative Office

Recruiting

Anderson, South Carolina, United States, 29621

Contacts

Theresa Knoepp, Site 0019

864-962-0431

Palmetto Clinical Trial Services - Administrative Office

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

Matthew Miller, Site 0190

864-962-0431

International Clinical Research (IC Research) - Murfreesboro

Recruiting

Murfreesboro, Tennessee, United States, 37130

Contacts

Christina Feser, Site 0336

615-410-3460

Arlington Center for Dermatology

Recruiting

Arlington, Texas, United States, 76011

Contacts

Angela Moore, Site 0057

817-795-7546

Studies in Dermatology, LLC

Recruiting

Cypress, Texas, United States, 77429

Contacts

Lauren Campbell, Site 0178

346-818-5204

Modern Research Associates, PLLC

Recruiting

Dallas, Texas, United States, 75231

Contacts

Jennifer Cather, Site 0086

214-361-2008

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75235

Contacts

Alice Gottlieb, Site 0468

241-645-8968

Center for Clinical Studies - Houston

Recruiting

Houston, Texas, United States, 77065

Contacts

Patricia Lee, Site 0500

+8498507

Texas Dermatology and Laser Specialists

Recruiting

San Antonio, Texas, United States, 78218

Contacts

John Browning, Site 0083

210-704-4037

Center For Clinical Studies

Recruiting

Webster, Texas, United States, 77598

Contacts

Stephen Tyring, Site 0381

713-528-8818

Frontier Derm Partners CRO LLC

Recruiting

Mill Creek, Washington, United States, 98012

Contacts

Eingun Song, Site 0186

425-275-4404

Premier Clinical Research

Recruiting

Spokane, Washington, United States, 99202

Contacts

William Werschler, Site 0175

509-343-3710

Dermatology Research Institute

Recruiting

Calgary, Alberta, Canada, T2J 7E1

Contacts

Vimal Prajapati, Site 0013

403-263-3376

Beacon Dermatology

Recruiting

Calgary, Alberta, Canada, T3E 0B2

Contacts

Andrei Metelitsa, Site 0288

4039262934

Laser Rejuvenation Clinics Edmonton D.T. Inc.

Recruiting

Edmonton, Alberta, Canada, T5J 3S9

Contacts

Parbeer Grewal, Site 0016

7804285767

Stratica Dermatology

Recruiting

Edmonton, Alberta, Canada, T5K 1X3

Contacts

Andrew Ferrier, Site 0184

7804285554

Alberta Dermasurgery Centre

Recruiting

Edmonton, Alberta, Canada, T6G 1C3

Vida Clinic Research

Recruiting

Edmonton, Alberta, Canada, T6H 4J8

Contacts

Anil Kurian, Site 0491

780-761-8432

Interior Dermatology Centre

Recruiting

Kelowna, British Columbia, Canada, V1W 4V5

Contacts

Dianne Burrows, Site 0497

236-766-0709

Skin Care West

Recruiting

Nanaimo, British Columbia, Canada, V9V 1A3

Contacts

Gabriele Weichert, Site 0431

250-740-2125

Enverus Medical Research

Recruiting

Surrey, British Columbia, Canada, V3V 0C6

Contacts

Lorne Albrecht, Site 0006

6044958278

Wiseman Dermatology Research Inc.

Recruiting

Winnipeg, Manitoba, Canada, R3M 3Z4

Contacts

Marni Wiseman, Site 0023

12049570185

Dr Tracey Brown-Maher Dermatology Clinic and Research Centre

Recruiting

St. John's, Newfoundland and Labrador, Canada, A1E 1V4

Contacts

Tracey Brown-Maher, Site 0098

709-728-1563

CCA Medical Research

Recruiting

Ajax, Ontario, Canada, L1S 7K8

Contacts

David Adam, Site 0073

15195794098

SimcoDerm Medical and Surgical Dermatology Center

Recruiting

Barrie, Ontario, Canada, L4M 7G1

Contacts

Maryam Alam, Site 0007

7055036331

Centricity Research London Victoria Multispecialty

Recruiting

London, Ontario, Canada, N6A 2C2

Contacts

Jeffery Cowger, Site 0004

5198731654

Lovegrove Dermatology

Recruiting

London, Ontario, Canada, N6A 5R9

Contacts

Fiona Lovegrove, Site 0430

519-204-3959

DermEffects

Recruiting

London, Ontario, Canada, N6H 5L5

Contacts

Wei Jing Loo, Site 0137

2269197887

Lynderm Research Inc.

Recruiting

Markham, Ontario, Canada, L3P 1X3

Contacts

Charles Walter Lynde, Site 0300

9054718011

DermEdge

Recruiting

Mississauga, Ontario, Canada, L4Y 4C5

Contacts

Mark Lomaga, Site 0141

9052749996

Ryan Clinical Research Inc

Recruiting

Newmarket, Ontario, Canada, L3Y 5G8

Contacts

Sanjay Siddha, Site 0080

4166035800

North Bay Dermatology Centre

Recruiting

North Bay, Ontario, Canada, P1B 3Z7

Contacts

Leslie Rosoph, Site 0489

17054763967

The Centre for Clinical Trials Inc.

Recruiting

Oakville, Ontario, Canada, L6J 7W5

Contacts

Sheetal Sapra, Site 0498

9058422262

JRB Research Inc.

Recruiting

Ottawa, Ontario, Canada, K1K 4L2

Contacts

Jennifer Beecker, Site 0003

6135234921

SKiN Centre for Dermatology

Recruiting

Peterborough, Ontario, Canada, K9J 5K2

Contacts

Melinda Gooderham, Site 0025

+1 705-761-7247

The Centre for Dermatology

Recruiting

Richmond Hill, Ontario, Canada, L4B 1A5

Contacts

Mani Raman, Site 0488

905-889-2005

North York Research Inc.

Recruiting

Toronto, Ontario, Canada, M2N 3A6

Contacts

Firouzeh Niakosari, Site 0042

14162217546

Toronto Research Centre

Recruiting

Toronto, Ontario, Canada, M3H 5Y8

Avenue Research Group

Recruiting

Toronto, Ontario, Canada, M5N 1A8

Contacts

Maxwell Sauder, Site 0506

4166330001

Centre de Recherche Saint-Louis

Recruiting

Montreal, Quebec, Canada, H1Y 3L1

Centre de Recherche Saint-Louis

Recruiting

Sherbrooke, Quebec, Canada, J1G 1X9

Contacts

Evelyn Alarcon Chinchilla, Site 0477

1 888 728 9142

Sima Recherche

Recruiting

Verdun, Quebec, Canada, H4G 3E7

Contacts

Simon Nigen, Site 0142

4384979184

Centre de Recherche Saint-Louis

Recruiting

Québec, Canada, G1W 4R4

Contacts

Virginie Kelly, Site 0017

418-780-3501

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Keywords

  • Deucravacitinib
  • Plaque psoriasis
  • Cardiovascular risk
  • PRAGMATYK

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.