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Reduktion af uønskede vaskulære hændelser med faktor XI-hæmning hos voksne deltagere med perifer arteriel sygdom (ROXI-PALISADE)

3. november 2026 opdateret af: Regeneron Pharmaceuticals

En hovedprotokol for en fase 3, multicenter, randomiseret undersøgelse til evaluering af effektiviteten og sikkerheden af REGN7508 og REGN9933, monoklonale antistoffer mod faktor XI, hos deltagere med nylig revaskularisering af nedre ekstremitet til symptomatisk perifer arteriel sygdom (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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

7050

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Kohorte 1
Medicin: Placebo

Administered per the protocol

Medicin: REGN7508

Administered per the protocol

Andre navne:
  • cenvacibart
Medicin: REGN9933

Administered per the protocol

Andre navne:
  • amrecibart
Eksperimentel: Kohorte 2
Medicin: REGN7508

Administered per the protocol

Andre navne:
  • cenvacibart
Medicin: REGN9933

Administered per the protocol

Andre navne:
  • amrecibart
Medicin: Rivaroxaban

Administered per the protocol

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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
Tidsramme: Approximately up to 42 months

Cohort 1 and 2
Approximately up to 42 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Approximately up to 42 months

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Cohort 2
Approximately up to 42 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Regeneron Pharmaceuticals

Efterforskere

  • Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. juli 2026

Primær færdiggørelse (Anslået)

18. august 2029

Studieafslutning (Anslået)

16. november 2029

Datoer for studieregistrering

Først indsendt

2. januar 2026

Først indsendt, der opfyldte QC-kriterier

2. januar 2026

Først opslået (Faktiske)

6. januar 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R9933-PAD-2394
  • 2025-522954-37-00 (Ctis)
  • 2025 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner