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Reduksjon av uønskede vaskulære hendelser med faktor XI-hemming hos voksne deltakere med perifer arteriell sykdom (ROXI-PALISADE)

3. november 2026 oppdatert av: Regeneron Pharmaceuticals

En hovedprotokoll for en fase 3, multicenter, randomisert studie for å evaluere effektiviteten og sikkerheten til REGN7508 og REGN9933, monoklonale antistoffer mot faktor XI, hos deltakere med nylig revaskularisering av nedre ekstremitet for symptomatisk perifer arteriesykdom (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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

7050

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Kohort 1
Legemiddel: Placebo

Administered per the protocol

Legemiddel: REGN7508

Administered per the protocol

Andre navn:
  • cenvacibart
Legemiddel: REGN9933

Administered per the protocol

Andre navn:
  • amrecibart
Eksperimentell: Kohort 2
Legemiddel: REGN7508

Administered per the protocol

Andre navn:
  • cenvacibart
Legemiddel: REGN9933

Administered per the protocol

Andre navn:
  • amrecibart
Legemiddel: Rivaroxaban

Administered per the protocol

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Regeneron Pharmaceuticals

Etterforskere

  • Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. juli 2026

Primær fullføring (Antatt)

18. august 2029

Studiet fullført (Antatt)

16. november 2029

Datoer for studieregistrering

Først innsendt

2. januar 2026

Først innsendt som oppfylte QC-kriteriene

2. januar 2026

Først lagt ut (Faktiske)

6. januar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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

Tilgangskriterier for IPD-deling

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 Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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