Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Plaque Psoriasis
Спонсор: Bristol-Myers Squibb
Налично на:
БГ
Обобщение
A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
Кой може да участва
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.
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