Loading clinical trials...

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants With Moderate-to-Severe Plaque Psoriasis

NCT07116967•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

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).

Locations (341)

Local Institution - 0088

Birmingham, Alabama, United States

Medical Dermatology Specialists - Phoenix

Phoenix, Arizona, United States

Saguaro Dermatology - Phoenix

Phoenix, Arizona, United States

Omni Dermatology

Phoenix, Arizona, United States

Alliance Dermatology

Phoenix, Arizona, United States

Local Institution - 0322

Scottsdale, Arizona, United States

Local Institution - 0188

Scottsdale, Arizona, United States

Scottsdale Clinical Trials

Scottsdale, Arizona, United States

Omni Dermatology

Tempe, Arizona, United States

Clinical Trials Institute of Northwest Arkansas

Fayetteville, Arkansas, United States

Key Dates

Start Date

September 22, 2025

Primary Completion Date

January 16, 2031

Completion Date

January 16, 2031

Last Updated

March 10, 2026

Enrollment

3,040

ESTIMATED participants

Conditions

Plaque Psoriasis

Interventions

Deucravacitinib

DRUG

Ustekinumab

DRUG

Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

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

First line of the email MUST contain NCT # and Site #.

CONTACT

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Plaque Psoriasis

View study

RECRUITINGPHASE2

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

NCT07449702

Plaque Psoriasis

View study

RECRUITINGPHASE2

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

NCT07290569

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

Inclusion Criteria

Exclusion Criteria

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis

A Study of Switching to Picankibart in Chinese Patients With Plaque Psoriasis With an Inadequate Response to Interleukin-17 Monoclonal Antibody Therapy