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Riduzione degli eventi vascolari avversi mediante inibizione del fattore XI in partecipanti adulti con malattia arteriosa periferica (ROXI-PALISADE)

3 novembre 2026 aggiornato da: Regeneron Pharmaceuticals

Un Protocollo Master per uno Studio di Fase 3, Multicentrico, Randomizzato per Valutare l'Efficacia e la Sicurezza di REGN7508 e REGN9933, Anticorpi Monoclonali Contro il Fattore XI, in Partecipanti con Recente Rivascolarizzazione dell'Arto Inferiore per Malattia Arteriosa Periferica Sintomatica (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

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

7050

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Coorte 1
Droga: Placebo

Administered per the protocol

Droga: REGN7508

Administered per the protocol

Altri nomi:
  • cenvacibart
Droga: REGN9933

Administered per the protocol

Altri nomi:
  • amrecibart
Sperimentale: Coorte 2
Droga: REGN7508

Administered per the protocol

Altri nomi:
  • cenvacibart
Droga: REGN9933

Administered per the protocol

Altri nomi:
  • amrecibart
Droga: Rivaroxaban

Administered per the protocol

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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
Lasso di tempo: Approximately up to 42 months

Cohort 1 and 2
Approximately up to 42 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Approximately up to 42 months

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

Cohort 1
Approximately up to 42 months
Time-to-first occurrence of VTE
Lasso di tempo: Approximately up to 42 months

Cohort 1
Approximately up to 42 months
Time-to-all-cause mortality
Lasso di tempo: Approximately up to 42 months

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

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

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

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

Cohort 1 and 2
Approximately up to 45 months
Severity of TEAEs
Lasso di tempo: Approximately up to 45 months

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

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

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

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

Cohort 1 and 2
Approximately up to 45 months
Concentrations of REGN7508 over time
Lasso di tempo: Approximately up to 45 months

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

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

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

Cohort 2
Approximately up to 42 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Regeneron Pharmaceuticals

Investigatori

  • Direttore dello studio: Clinical Trial Management, Regeneron Pharmaceuticals

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 luglio 2026

Completamento primario (Stimato)

18 agosto 2029

Completamento dello studio (Stimato)

16 novembre 2029

Date di iscrizione allo studio

Primo inviato

2 gennaio 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 gennaio 2026

Primo Inserito (Effettivo)

6 gennaio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • R9933-PAD-2394
  • 2025-522954-37-00 (Ctis)
  • 2025 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Periodo di condivisione 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

Criteri di accesso alla condivisione 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 di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • CODICE_ANALITICO
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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