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ID del estudio IM011-1130  |   NCT07116967

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

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Lo sentimos, este estudio aún no acepta participantes.
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Resumen

  • Phase 3
  • Ícono de género masculino y femenino
  • 40+
  • 140
  • Ícono de BMS, estudio No reclutando aún
    Not Yet Recruiting

Descripción general

A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis

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Criterios clave de elegibilidad

Criterios de inclusión

Criterios de inclusión Icon
:
  • 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:
    1. Current cigarette smoker
      1. Diagnosis of hypertension
        1. Diagnosis of hyperlipidemia
          1. Diabetes mellitus type 1 or 2
            1. 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
              1. Obesity
                1. 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.

                  Criterios de exclusión

                  Criterios de exclusión Icon
                  :
                  • 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.
                    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.
                      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).
                        1. Other protocol define inclusion/exclusion criteria apply.
                          Información Adicional *

                          Opciones de tratamiento

                          Brazos del estudio

                          INTERVENCIÓN ASIGNADA

                          Brazos del estudio

                          Experimental: Arm A

                          INTERVENCIÓN ASIGNADA
                          • Drug: Deucravacitinib

                          Brazos del estudio

                          Active Comparator: Arm B

                          INTERVENCIÓN ASIGNADA
                          • Drug: Ustekinumab
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