Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease

NCT07318610
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
7,050
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Lead sponsor
Regeneron Pharmaceuticals
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Start date
2026-07-10
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Number of sites
17
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Summary
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
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Acronym
ROXI-PALISADE
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Short title
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
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Official title
A Master Protocol for a Phase 3, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, in Participants With Recent Lower Extremity Revascularization for Symptomatic Peripheral Artery Disease (ROXI-PALISADE)
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Registry reports results
No
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Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2029-11-16
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First posted
2026-01-06
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Registry last updated
2026-08-19
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Primary completion date
2029-08-18
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Start date
2026-07-10
clinicaltrials.gov

Participants
7,050
clinicaltrials.gov
Participant count basis
Estimated
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Planned participants
7,050
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Protocol amendments
1
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Number of sites
17
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Regeneron Pharmaceuticals
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07318610
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07318610
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masking description
Cohort 1 of this study is double-blinded, and for Cohort 2 the participants, sponsor, and the investigators will be blinded to REGN7508 or REGN9933, but rivaroxaban will be administered as open-label.
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. 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

    Timeframe: Approximately up to 42 months

    Cohort 1

  2. Time-to-first occurrence of International Society of Thrombosis and Hemostasis (ISTH) major or Clinically Relevant Non-major (CRNM) bleeding

    Timeframe: Approximately up to 42 months

    Cohort 1 and 2

  1. 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

    Timeframe: Approximately up to 42 months

    Cohort 1 and 2

  2. 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)

    Timeframe: Approximately up to 42 months

    Cohort 1 and 2

  3. Time-to-first occurrence of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke or coronary death

    Timeframe: Approximately up to 42 months

    Cohort 1

  4. Time-to-first occurrence of vascular hospitalization for a coronary cerebrovascular, or peripheral event of thrombotic nature

    Timeframe: Approximately up to 42 months

    Cohort 1

  5. Time-to-first occurrence of ALI, major amputation of vascular etiology, MI, ischemic stroke, or all-cause mortality

    Timeframe: Approximately up to 42 months

    Cohort 1

  6. Time-to-first occurrence of unplanned index limb revascularization for ischemia

    Timeframe: Approximately up to 42 months

    Cohort 1

  7. Time-to-first occurrence of VTE

    Timeframe: Approximately up to 42 months

    Cohort 1

  8. Time-to-all-cause mortality

    Timeframe: Approximately up to 42 months

    Cohort 1

  9. Time-to-first occurrence of Major Adverse Limb Event (MALE)

    Timeframe: Approximately up to 42 months

    Cohort 1

  10. Time-to-first occurrence of Major Adverse Cardiovascular Event (MACE)

    Timeframe: Approximately up to 42 months

    Cohort 1

  11. Time-to-first occurrence of a major thrombotic vascular event or ISTH fatal/critical organ bleeding (net clinical benefit)

    Timeframe: Approximately up to 42 months

    Cohort 1

  12. Time-to-first occurrence of Thrombolysis in Myocardial Infarction (TIMI) major bleeding

    Timeframe: Approximately up to 42 months

    Cohort 1 and 2

  13. Occurrence of Treatment-Emergent Adverse Event (TEAEs)

    Timeframe: Approximately up to 45 months

    Cohort 1 and 2

  14. Severity of TEAEs

    Timeframe: Approximately up to 45 months

    Cohort 1 and 2

  15. Occurrence of Anti-Drug Antibody (ADA) to REGN7508 over time

    Timeframe: Approximately up to 45 months

    Cohort 1 and 2

  16. Magnitude of ADA to REGN7508 over time

    Timeframe: Approximately up to 45 months

    Cohort 1 and 2

  17. Occurrence of ADA to REGN9933 over time

    Timeframe: Approximately up to 45 months

    Cohort 1 and 2

  18. Magnitude of ADA to REGN9933 over time

    Timeframe: Approximately up to 45 months

    Cohort 1 and 2

  19. Concentrations of REGN7508 over time

    Timeframe: Approximately up to 45 months

    Cohort 1 and 2

  20. Concentrations of REGN9933 over time

    Timeframe: Approximately up to 45 months

    Cohort 1 and 2

  21. Change from baseline in activated Partial Thromboplastin Time (aPTT) over time

    Timeframe: Approximately up to week 9

    Cohort 1 and 2

  22. Change from baseline in Prothrombin Time (PT)/International Normalization Ratio (INR) over time

    Timeframe: Approximately up to week 9

    Cohort 1 and 2

  23. Total (first and subsequent) occurrences of expanded thrombotic vascular events

    Timeframe: Approximately up to 42 months

    Cohort 2

  24. Time-to-first occurrence of a major thrombotic vascular event

    Timeframe: Approximately up to 42 months

    Cohort 2

  25. Total (first and subsequent) occurrences of ALI, major amputation (above the ankle) of vascular etiology, MI, all-cause stroke, or CV death

    Timeframe: Approximately up to 42 months

    Cohort 2

And 1 more, listed on the interactive page.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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

Sources for eligibility
clinicaltrials.gov

  • Lake Martin Medical and Vascular CenterAlexander City, United StatesRecruiting
  • Axsendo Clinical Research, Integrated Medical ServicesAvondale, United StatesRecruiting
  • Applied Research Center of ArkansasLittle Rock, United StatesRecruiting
  • Angel City Research, Inc.Los Angeles, United StatesRecruiting
  • Pacific Cardiovascular and Vein InstituteOxnard, United StatesRecruiting
  • Nature Coast Clinical Research - CardiologyCrystal River, United StatesRecruiting
  • Profound Research, Powers Health Medical GroupMunster, United StatesRecruiting
  • Cardiovascular SolutionsShreveport, United StatesRecruiting
  • Accellacare of Piedmont, Piedmont HealthcareMooresville, United StatesRecruiting
  • Hightower ClinicalOklahoma City, United StatesRecruiting
  • Apex Research Foundation, LLCJackson, United StatesRecruiting
  • Tennova TCMCKnoxville, United StatesRecruiting
  • Vanderbilt Heart and Vascular Tullahoma, Cardiology and Vascular AssociatesTullahoma, United StatesRecruiting
  • PharmaTex ResearchAmarillo, United StatesRecruiting
  • Vital Heart and VeinCypress, United StatesRecruiting
  • Epic Medical ResearchDeSoto, United StatesRecruiting
  • Epic Medical Research-PlanoPlano, United StatesRecruiting
Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-522954-37-00
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (2)

Targets (3)