Plaque Psoriasis
Conditions
Interventions
Deucravacitinib or ustekinumab at a specific dose on a specific day
Sponsors
Leonardis De Francesco
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - Having recent history of 1 of the following cardiovascular events: -- MI, stroke, or coronary revascularization, or VTE within 90 days prior to Day 1. -- 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. - Having 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MACE defined as non-fatal myocardial infarction [MI], nonfatal stroke, and cardiovascular death | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with non-fatal MI Number of participants with non-fatal stroke Death due to cardiovascular events Number of participants with coronary revascularization Number of participants with 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death) Number of participants with pulmonary embolism (PE) Number of participants with deep vein thrombosis (DVT) Number of participants with composite venous thromboembolism (VTE) Number of participants with arterial thromboembolic events (including retinal artery occlusion) Number of participants with heart failure (HF) requiring hospitalization or urgent visit Number of participants with Malignancy excluding non-melanoma skin cancer (NMSC) Number of participants with NMSC Number of participants with opportunistic infections Number of participants with Serious AEs (SAEs) All-cause mortality AEs leading to permanent treatment discontinuation Change from baseline in liver function test Change from baseline in fasting lipid panel | — |
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
Public ContactFrancesco Leonardis
Bristol-Myers Squibb
Outcome results
None listed