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Reducción de resultados vasculares adversos con inhibición del factor XI en participantes adultos con enfermedad arterial periférica (ROXI-PALISADE)

3 de noviembre de 2026 actualizado por: Regeneron Pharmaceuticals

Un Protocolo Maestro para un Estudio de Fase 3, Multicéntrico y Aleatorizado para Evaluar la Eficacia y Seguridad de REGN7508 y REGN9933, Anticuerpos Monoclonales contra el Factor XI, en Participantes con Revascularización Reciente de las Extremidades Inferiores por Enfermedad Arterial Periférica Sintomática (ROXI-PALISADE)

This study is researching 2 different experimental drugs called REGN7508 and REGN9933. The study is focused on people who have Peripheral Artery Disease (PAD), which means that the blood vessels in their arms and legs have become too narrow. People with PAD have a higher risk of getting blood clots after procedures like Lower Extremity Revascularization (LER), a procedure to improve blood flow in the legs and feet.

The aim of this study is to see how well REGN7508 and REGN9933 prevent life-threatening blood clots in participants with PAD who have recently had LER. The effects of REGN7508 and REGN9933, individually, will also be compared to rivaroxaban and a placebo.

The study is looking at several other research questions, including:

  • What side effects might happen from taking the study drugs and how do they compare to the side effects of rivaroxaban
  • How much study drug is in the blood at different times
  • Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)
  • If the study drugs affect the ability of the blood to clot normally

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

7050

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Estados Unidos
    • Alabama
      • Alexander City, Alabama, Estados Unidos, 35010
        • Reclutamiento
        • Lake Martin Medical and Vascular Center
      • Alexander City, Alabama, Estados Unidos, 35010
        • Reclutamiento
        • Advanced Cardiovascular
    • Arizona
      • Avondale, Arizona, Estados Unidos, 85392
        • Reclutamiento
        • Axsendo Clinical Research, Integrated Medical Services
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos, 72205
        • Reclutamiento
        • Applied Research Center of Arkansas
    • California
      • Los Angeles, California, Estados Unidos, 90010
        • Reclutamiento
        • Angel City Research, Inc.
      • Oxnard, California, Estados Unidos, 93036
        • Reclutamiento
        • Pacific Cardiovascular and Vein Institute
      • West Hills, California, Estados Unidos, 91307
        • Reclutamiento
        • Interventional Cardiology Medical Group
    • Florida
      • Crystal River, Florida, Estados Unidos, 34429
        • Reclutamiento
        • Nature Coast Clinical Research - Cardiology
      • Jacksonville, Florida, Estados Unidos, 32209
        • Reclutamiento
        • University of Florida (UF) Health Jacksonville Clinical Center
      • Miami Lakes, Florida, Estados Unidos, 33014
        • Reclutamiento
        • Inpatient Research Clinic LLC
      • Panama City, Florida, Estados Unidos, 32405
        • Reclutamiento
        • Cardiovascular Institute of Northwest Florida, Main Office
      • Tampa, Florida, Estados Unidos, 33614
        • Reclutamiento
        • Tampa Cardiovascular Interventions and Research
    • Indiana
      • Fort Wayne, Indiana, Estados Unidos, 46804
        • Reclutamiento
        • Lutheran Medical Group LLC dba Lutheran Health Physicians
      • Hammond, Indiana, Estados Unidos, 46324
        • Reclutamiento
        • ASHA Clinical Research Munster, LLC
      • Munster, Indiana, Estados Unidos, 46321
        • Reclutamiento
        • Profound Research, Powers Health Medical Group
    • Louisiana
      • Shreveport, Louisiana, Estados Unidos, 71103
        • Reclutamiento
        • Cardiovascular Solutions
    • Mississippi
      • Petal, Mississippi, Estados Unidos, 39465
        • Reclutamiento
        • Rovia Clinical Research - Hattiesburg Clinic
    • New Jersey
      • Flemington, New Jersey, Estados Unidos, 08822
        • Reclutamiento
        • Advanced Heart and Vascular Institute of Hunterdon
    • New York
      • Valhalla, New York, Estados Unidos, 10595
        • Reclutamiento
        • Westchester Medical Center
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28207
        • Reclutamiento
        • Mecklenburg Heart Specialists Vascular Institute and Vein Center
      • Mooresville, North Carolina, Estados Unidos, 28117
        • Reclutamiento
        • Accellacare of Piedmont, Piedmont Healthcare
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73102
        • Reclutamiento
        • Hightower Clinical
    • South Dakota
      • Rapid City, South Dakota, Estados Unidos, 57701
        • Reclutamiento
        • Monument Health Clinical Research
    • Tennessee
      • Jackson, Tennessee, Estados Unidos, 38301
        • Reclutamiento
        • Apex Research Foundation, LLC
      • Knoxville, Tennessee, Estados Unidos, 37934
        • Reclutamiento
        • Tennova TCMC
      • Tullahoma, Tennessee, Estados Unidos, 37388
        • Reclutamiento
        • Vanderbilt Heart and Vascular Tullahoma, Cardiology and Vascular Associates
    • Texas
      • Amarillo, Texas, Estados Unidos, 79106
        • Reclutamiento
        • PharmaTex Research
      • Cypress, Texas, Estados Unidos, 77429
        • Reclutamiento
        • Vital Heart and Vein
      • DeSoto, Texas, Estados Unidos, 75115
        • Reclutamiento
        • Epic Medical Research
      • Plano, Texas, Estados Unidos, 75093
        • Reclutamiento
        • Epic Medical Research-Plano
  • Reino Unido
      • Doncaster, Reino Unido, DN2 5LT
        • Reclutamiento
        • Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
      • London, Reino Unido, W6 8RF
        • Reclutamiento
        • Charing Cross Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Key Inclusion Criteria:

  1. Successful LER distal to the external iliac artery for ischemia due to atherosclerotic disease within 10 days prior to randomization as described in the protocol

  2. At least 1 of the following enrichment factors for major thrombotic vascular events:

    1. Bypass with prosthetic graft
    2. Endovascular treatment with stenting
    3. Target lesion length >15 cm
    4. History of LER or amputation for PAD prior to qualifying LER
    5. Type 2 diabetes mellitus requiring pharmacologic treatment
    6. Comorbid symptomatic coronary artery disease as described in the protocol
    7. Chronic kidney disease as described in the protocol
    8. Age ≥75 years

Key Exclusion Criteria:

  1. Has any active clinical condition requiring chronic therapeutic anticoagulation after the index revascularization including known triple positive antiphospholipid syndrome
  2. Has known bleeding diathesis, platelet count <50,000/mm^3 or history of non-traumatic intracerebral hemorrhage, known cerebral amyloid angiopathy, or known unrepaired cerebrovascular malformations
  3. Has recent coronary revascularization as described in the protocol
  4. For Cohort 2 only: Has estimated Glomerular Filtration Rate (eGFR) <15 mL/min/1.73m^2 within 14 days prior to randomization or on dialysis or expected to be started on dialysis within the next 12 weeks starting from randomization
  5. Has any other condition or therapy which would make the participant unsuitable for this study or not allow participation for the full planned study period
  6. Has allergy, hypersensitivity, or other contraindication to REGN7508, REGN9933, or rivaroxaban (Cohort 2 only) or their excipients

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Cohorte 1
Droga: Placebo

Administered per the protocol

Droga: REGN7508

Administered per the protocol

Otros nombres:
  • cenvacibart
Droga: REGN9933

Administered per the protocol

Otros nombres:
  • amrecibart
Experimental: Cohorte 2
Droga: REGN7508

Administered per the protocol

Otros nombres:
  • cenvacibart
Droga: REGN9933

Administered per the protocol

Otros nombres:
  • amrecibart
Droga: Rivaroxaban

Administered per the protocol

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time-to-first occurrence of a major thrombotic vascular event, consisting of Acute Limb Ischemia (ALI), major amputation (above the ankle) of vascular etiology, Myocardial Infarction (MI), ischemic stroke, or Cardiovascular (CV) death
Periodo de tiempo: Approximately up to 42 months

Cohort 1
Approximately up to 42 months
Time-to-first occurrence of International Society of Thrombosis and Hemostasis (ISTH) major or Clinically Relevant Non-major (CRNM) bleeding
Periodo de tiempo: Approximately up to 42 months

Cohort 1 and 2
Approximately up to 42 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Total (first and subsequent) occurrences of major thrombotic vascular events, consisting of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke, or CV death
Periodo de tiempo: Approximately up to 42 months

Cohort 1 and 2
Approximately up to 42 months
Time-to-first occurrence of an expanded thrombotic vascular event, consisting of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke, CV death, unplanned index limb revascularization, or Venous Thromboembolism (VTE)
Periodo de tiempo: Approximately up to 42 months

Cohort 1 and 2
Approximately up to 42 months
Time-to-first occurrence of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke or coronary death
Periodo de tiempo: Approximately up to 42 months

Cohort 1
Approximately up to 42 months
Time-to-first occurrence of vascular hospitalization for a coronary cerebrovascular, or peripheral event of thrombotic nature
Periodo de tiempo: Approximately up to 42 months

Cohort 1
Approximately up to 42 months
Time-to-first occurrence of ALI, major amputation of vascular etiology, MI, ischemic stroke, or all-cause mortality
Periodo de tiempo: Approximately up to 42 months

Cohort 1
Approximately up to 42 months
Time-to-first occurrence of unplanned index limb revascularization for ischemia
Periodo de tiempo: Approximately up to 42 months

Cohort 1
Approximately up to 42 months
Time-to-first occurrence of VTE
Periodo de tiempo: Approximately up to 42 months

Cohort 1
Approximately up to 42 months
Time-to-all-cause mortality
Periodo de tiempo: Approximately up to 42 months

Cohort 1
Approximately up to 42 months
Time-to-first occurrence of Major Adverse Limb Event (MALE)
Periodo de tiempo: Approximately up to 42 months

Cohort 1
Approximately up to 42 months
Time-to-first occurrence of Major Adverse Cardiovascular Event (MACE)
Periodo de tiempo: Approximately up to 42 months

Cohort 1
Approximately up to 42 months
Time-to-first occurrence of a major thrombotic vascular event or ISTH fatal/critical organ bleeding (net clinical benefit)
Periodo de tiempo: Approximately up to 42 months

Cohort 1
Approximately up to 42 months
Time-to-first occurrence of Thrombolysis in Myocardial Infarction (TIMI) major bleeding
Periodo de tiempo: Approximately up to 42 months

Cohort 1 and 2
Approximately up to 42 months
Occurrence of Treatment-Emergent Adverse Event (TEAEs)
Periodo de tiempo: Approximately up to 45 months

Cohort 1 and 2
Approximately up to 45 months
Severity of TEAEs
Periodo de tiempo: Approximately up to 45 months

Cohort 1 and 2
Approximately up to 45 months
Occurrence of Anti-Drug Antibody (ADA) to REGN7508 over time
Periodo de tiempo: Approximately up to 45 months

Cohort 1 and 2
Approximately up to 45 months
Magnitude of ADA to REGN7508 over time
Periodo de tiempo: Approximately up to 45 months

Cohort 1 and 2
Approximately up to 45 months
Occurrence of ADA to REGN9933 over time
Periodo de tiempo: Approximately up to 45 months

Cohort 1 and 2
Approximately up to 45 months
Magnitude of ADA to REGN9933 over time
Periodo de tiempo: Approximately up to 45 months

Cohort 1 and 2
Approximately up to 45 months
Concentrations of REGN7508 over time
Periodo de tiempo: Approximately up to 45 months

Cohort 1 and 2
Approximately up to 45 months
Concentrations of REGN9933 over time
Periodo de tiempo: Approximately up to 45 months

Cohort 1 and 2
Approximately up to 45 months
Change from baseline in activated Partial Thromboplastin Time (aPTT) over time
Periodo de tiempo: Approximately up to week 9

Cohort 1 and 2
Approximately up to week 9
Change from baseline in Prothrombin Time (PT)/International Normalization Ratio (INR) over time
Periodo de tiempo: Approximately up to week 9

Cohort 1 and 2
Approximately up to week 9
Total (first and subsequent) occurrences of expanded thrombotic vascular events
Periodo de tiempo: Approximately up to 42 months

Cohort 2
Approximately up to 42 months
Time-to-first occurrence of a major thrombotic vascular event
Periodo de tiempo: Approximately up to 42 months

Cohort 2
Approximately up to 42 months
Total (first and subsequent) occurrences of ALI, major amputation (above the ankle) of vascular etiology, MI, all-cause stroke, or CV death
Periodo de tiempo: Approximately up to 42 months

Cohort 2
Approximately up to 42 months
Total (first and subsequent) occurrences of ALI, major amputation (above the ankle) of vascular etiology, MI, all-cause stroke, CV death, unplanned index limb revascularization, or VTE
Periodo de tiempo: Approximately up to 42 months

Cohort 2
Approximately up to 42 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Regeneron Pharmaceuticals

Investigadores

  • Director de estudio: Clinical Trial Management, Regeneron Pharmaceuticals

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

10 de julio de 2026

Finalización primaria (Estimado)

18 de agosto de 2029

Finalización del estudio (Estimado)

16 de noviembre de 2029

Fechas de registro del estudio

Enviado por primera vez

2 de enero de 2026

Primero enviado que cumplió con los criterios de control de calidad

2 de enero de 2026

Publicado por primera vez (Actual)

6 de enero de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • R9933-PAD-2394
  • 2025-522954-37-00 (Ctis)
  • 2025 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Marco de tiempo para compartir IPD

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

Criterios de acceso compartido de IPD

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • CÓDIGO_ANALÍTICO
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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