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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 3

Conditions: Plaque Psoriasis

Treatments: Drug: Ustekinumab; Drug: Deucravacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07116967

IM011-1130

2023-503766-24 (Other Identifier)

U1111-1291-5815 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 3,040 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No 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).
• Other protocol define inclusion/exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

3,040 participants in 2 patient groups

Arm A

Experimental group

Treatment:

Drug: Deucravacitinib

Arm B

Active Comparator group

Treatment:

Drug: Ustekinumab