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Not Yet Recruiting

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK) - IM011-1130

Aktualisiert: 13 August, 2025   |   ClinicalTrials.gov

Zusammenfassung zum Ausdrucken

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Studiendetails

  • Phase 3

    Phase

  • Geschlecht(er)

  • 40+

    Altersgruppe

  • 140

    Standort(e)

  • Not Yet Recruiting

Behandlungsmöglichkeiten

Studienarme
ZUGEWIESENE BEHANDLUNG
Experimental: Arm A
Drug: Deucravacitinib
Active Comparator: Arm B
Drug: Ustekinumab

Wichtigste Eignungskriterien

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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