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Réduction des issues vasculaires indésirables par inhibition du facteur XI chez les participants adultes atteints d'une maladie artérielle périphérique (ROXI-PALISADE)

3 novembre 2026 mis à jour par: Regeneron Pharmaceuticals

Un protocole maître pour une étude de phase 3, multicentrique, randomisée visant à évaluer l'efficacité et l'innocuité du REGN7508 et du REGN9933, anticorps monoclonaux anti-facteur XI, chez des participants ayant récemment subi une revascularisation des membres inférieurs pour une artériopathie périphérique symptomatique (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

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

7050

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Cohorte 1
Médicament: Placebo

Administered per the protocol

Médicament: REGN7508

Administered per the protocol

Autres noms:
  • cenvacibart
Médicament: REGN9933

Administered per the protocol

Autres noms:
  • amrecibart
Expérimental: Cohorte 2
Médicament: REGN7508

Administered per the protocol

Autres noms:
  • cenvacibart
Médicament: REGN9933

Administered per the protocol

Autres noms:
  • amrecibart
Médicament: Rivaroxaban

Administered per the protocol

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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
Délai: 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
Délai: Approximately up to 42 months

Cohort 1 and 2
Approximately up to 42 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: Approximately up to 42 months

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

Cohort 1
Approximately up to 42 months
Time-to-first occurrence of VTE
Délai: Approximately up to 42 months

Cohort 1
Approximately up to 42 months
Time-to-all-cause mortality
Délai: Approximately up to 42 months

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

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

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

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

Cohort 1 and 2
Approximately up to 45 months
Severity of TEAEs
Délai: Approximately up to 45 months

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

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

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

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

Cohort 1 and 2
Approximately up to 45 months
Concentrations of REGN7508 over time
Délai: Approximately up to 45 months

Cohort 1 and 2
Approximately up to 45 months
Concentrations of REGN9933 over time
Délai: 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
Délai: 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
Délai: Approximately up to week 9

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

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

Cohort 2
Approximately up to 42 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Regeneron Pharmaceuticals

Les enquêteurs

  • Directeur d'études: Clinical Trial Management, Regeneron Pharmaceuticals

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 juillet 2026

Achèvement primaire (Estimé)

18 août 2029

Achèvement de l'étude (Estimé)

16 novembre 2029

Dates d'inscription aux études

Première soumission

2 janvier 2026

Première soumission répondant aux critères de contrôle qualité

2 janvier 2026

Première publication (Réel)

6 janvier 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • R9933-PAD-2394
  • 2025-522954-37-00 (Ctis)
  • 2025 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage 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

Critères d'accès au partage 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

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • ANALYTIC_CODE
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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