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Het Verminderen van Ongewenste Vasculaire Uitkomsten Door Remming van Factor XI bij Volwassen Deelnemers met Perifeer Arterieel Vaatlijden (ROXI-PALISADE)

3 november 2026 bijgewerkt door: Regeneron Pharmaceuticals

Een masterprotocol voor een fase 3, multicenter, gerandomiseerde studie om de werkzaamheid en veiligheid van REGN7508 en REGN9933, monoklonale antilichamen tegen factor XI, te evalueren bij deelnemers met recente revascularisatie van de onderste ledematen voor symptomatische perifere arteriële ziekte (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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

7050

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Cohort 1
Geneesmiddel: Placebo

Administered per the protocol

Geneesmiddel: REGN7508

Administered per the protocol

Andere namen:
  • cenvacibart
Geneesmiddel: REGN9933

Administered per the protocol

Andere namen:
  • amrecibart
Experimenteel: Cohort 2
Geneesmiddel: REGN7508

Administered per the protocol

Andere namen:
  • cenvacibart
Geneesmiddel: REGN9933

Administered per the protocol

Andere namen:
  • amrecibart
Geneesmiddel: Rivaroxaban

Administered per the protocol

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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
Tijdsspanne: Approximately up to 42 months

Cohort 1 and 2
Approximately up to 42 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Approximately up to 42 months

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Cohort 2
Approximately up to 42 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Regeneron Pharmaceuticals

Onderzoekers

  • Studie directeur: Clinical Trial Management, Regeneron Pharmaceuticals

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 juli 2026

Primaire voltooiing (Geschat)

18 augustus 2029

Studie voltooiing (Geschat)

16 november 2029

Studieregistratiedata

Eerst ingediend

2 januari 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 januari 2026

Eerst geplaatst (Werkelijk)

6 januari 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 november 2026

Laatste update ingediend die voldeed aan QC-criteria

3 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • R9933-PAD-2394
  • 2025-522954-37-00 (Ctis)
  • 2025 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD-tijdsbestek voor delen

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-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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