Plaque Psoriasis
Conditions
Keywords
Deucravacitinib, Plaque psoriasis, Cardiovascular risk, PRAGMATYK
Brief summary
A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
Interventions
DRUGDeucravacitinib
Specified dose on specified days
DRUGUstekinumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with deep vein thrombosis (DVT) | 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 Malignancy excluding non-melanoma skin cancer (NMSC) | Up to 5 years | — |
| Number of participants with NMSC | 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 Serious AEs (SAEs) | Up to 60 days after last dose | — |
| All-cause mortality | 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 non-fatal MI | Up to 5 years | — |
| Number of participants with non-fatal stroke | Up to 5 years | — |
| Death due to cardiovascular events | Up to 5 years | — |
| Number of participants with coronary revascularization | Up to 5 years | — |
| Number of participants with pulmonary embolism (PE) | Up to 5 years | — |
| Number of participants with 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death) | Up to 5 years | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, Denmark, France, Germany, Hungary, Italy, Japan, Mexico, Poland, Puerto Rico, Romania, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed