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Minska risken för kärlrelaterade komplikationer genom hämning av faktor XI hos vuxna deltagare med perifer kärlsjukdom (ROXI-PALISADE)

3 november 2026 uppdaterad av: Regeneron Pharmaceuticals

En huvudprotokoll för en fas 3, multicenter, randomiserad studie för att utvärdera effektiviteten och säkerheten hos REGN7508 och REGN9933, monoklonala antikroppar mot faktor XI, hos deltagare med nyligen genomförd revaskularisering av nedre extremiteten för symtomgivande perifer artärsjukdom (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

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

7050

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Kohort 1
Läkemedel: Placebo

Administered per the protocol

Läkemedel: REGN7508

Administered per the protocol

Andra namn:
  • cenvacibart
Läkemedel: REGN9933

Administered per the protocol

Andra namn:
  • amrecibart
Experimentell: Kohort 2
Läkemedel: REGN7508

Administered per the protocol

Andra namn:
  • cenvacibart
Läkemedel: REGN9933

Administered per the protocol

Andra namn:
  • amrecibart
Läkemedel: Rivaroxaban

Administered per the protocol

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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
Tidsram: 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
Tidsram: Approximately up to 42 months

Cohort 1 and 2
Approximately up to 42 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Approximately up to 42 months

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Cohort 2
Approximately up to 42 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Regeneron Pharmaceuticals

Utredare

  • Studierektor: Clinical Trial Management, Regeneron Pharmaceuticals

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

10 juli 2026

Primärt slutförande (Beräknad)

18 augusti 2029

Avslutad studie (Beräknad)

16 november 2029

Studieregistreringsdatum

Först inskickad

2 januari 2026

Först inskickad som uppfyllde QC-kriterierna

2 januari 2026

Första postat (Faktisk)

6 januari 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Tidsram för IPD-delning

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

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • ANALYTIC_CODE
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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