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Cerca in Study Connect

Not Yet Recruiting

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

Aggiornato: 13 agosto, 2025   |   ClinicalTrials.gov.

Stampi il riassunto semplice

STA PRENDENDO IN CONSIDERAZIONE QUESTA SPERIMENTAZIONE?
Stampi questa pagina e la guida alla sperimentazione da utilizzare come supporto nel colloquio con il Suo medico.
Utilizzi la Guida per i partecipanti allo studio per esplorare il processo di partecipazione a una sperimentazione clinica. Comprenda i fattori chiave da considerare prima di decidere e pensi alle domande da porre al Suo team di professionisti sanitari.

Dettagli della sperimentazione

  • Phase 3

    Fase

  • Sesso

  • 40+

    Fascia d'età

  • 140

    Sede/i

  • Not Yet Recruiting

Opzioni di trattamento

Bracci dello studio
INTERVENTO ASSEGNATO
Experimental: Arm A
Drug: Deucravacitinib
Active Comparator: Arm B
Drug: Ustekinumab

Principali criteri di idoneità

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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Segnala effetti collaterali (eventi avversi) o reclami sulla qualità del prodotto: informazioni mediche