Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
- Conditions
- Plaque Psoriasis
- Interventions
- Registration Number
- NCT07116967
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 3040
-
Participants with moderate-to-severe plaque psoriasis:
- Deemed by the Investigator to be a candidate for phototherapy or systemic treatment for psoriasis, including ustekinumab;
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Deucravacitinib - Arm B Ustekinumab -
- Primary Outcome Measures
Name Time Method Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization Up to 5 years MACE defined as non-fatal myocardial infarction \[MI\], nonfatal stroke, and cardiovascular death
- Secondary Outcome Measures
Name Time Method Death due to cardiovascular events Up to 5 years All-cause mortality Up to 60 days after last dose Number of participants with non-fatal MI Up to 5 years Number of participants with coronary revascularization Up to 5 years Number of participants with composite venous thromboembolism (VTE) Up to 5 years PE, DVT and retinal vein occlusion
Number of participants with arterial thromboembolic events (including retinal artery occlusion) Up to 5 years Number of participants with heart failure (HF) requiring hospitalization or urgent visit Up to 5 years Number of participants with opportunistic infections Up to 5 years Opportunistic infections include tuberculosis and complicated herpes zoster (eg, disseminated herpes zoster, affecting more than 2 dermatomes, ophthalmic or meningoencephalopathic involvement, and other atypical presentations)
Number of participants with non-fatal stroke Up to 5 years Number of participants with pulmonary embolism (PE) Up to 5 years Number of participants with deep vein thrombosis (DVT) Up to 5 years Number of participants with Serious AEs (SAEs) Up to 60 days after last dose AEs leading to permanent treatment discontinuation Up to 60 days after last dose Change from baseline in liver function test Up to 60 days after last dose Change from baseline in fasting lipid panel Up to 60 days after last dose Number of participants with 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death) Up to 5 years Number of participants with Malignancy excluding non-melanoma skin cancer (NMSC) Up to 5 years Number of participants with NMSC Up to 5 years
Trial Locations
- Locations (241)
Local Institution - 0088
🇺🇸Birmingham, Alabama, United States
Local Institution - 0107
🇺🇸Phoenix, Arizona, United States
Local Institution - 0322
🇺🇸Scottsdale, Arizona, United States
Local Institution - 0188
🇺🇸Scottsdale, Arizona, United States
Local Institution - 0432
🇺🇸Scottsdale, Arizona, United States
Local Institution - 0335
🇺🇸Fayetteville, Arkansas, United States
Local Institution - 0179
🇺🇸Los Angeles, California, United States
Local Institution - 0192
🇺🇸Los Angeles, California, United States
Local Institution - 0411
🇺🇸Northridge, California, United States
Local Institution - 0426
🇺🇸Palmdale, California, United States
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