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NCT Number: NCT07318610

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

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

Recruiting

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Key information

Conditions

Peripheral Artery Disease (PAD) Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Embolism and Thrombosis Peripheral Arterial Disease Peripheral Vascular Diseases Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Lake Martin Medical and Vascular Center, Alexander City, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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
  • At least 1 of the following enrichment factors for major thrombotic vascular events:
  • Bypass with prosthetic graft
  • Endovascular treatment with stenting
  • Target lesion length >15 cm
  • History of LER or amputation for PAD prior to qualifying LER
  • Type 2 diabetes mellitus requiring pharmacologic treatment
  • Comorbid symptomatic coronary artery disease as described in the protocol
  • Chronic kidney disease as described in the protocol
  • Age ≥75 years

Key Exclusion Criteria:

  • Has any active clinical condition requiring chronic therapeutic anticoagulation after the index revascularization including known triple positive antiphospholipid syndrome
  • 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
  • Has recent coronary revascularization as described in the protocol
  • 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
  • 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
  • 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

Treatment and study plan

REGN7508

Drug

Administered per the protocol

Other names: cenvacibart

REGN9933

Drug

Administered per the protocol

Other names: amrecibart

Placebo

Drug

Administered per the protocol

Rivaroxaban

Drug

Administered per the protocol

Primary outcomes

  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

    Time frame: 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

    Time frame: Approximately up to 42 months

    Cohort 1 and 2

Secondary outcomes

  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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Approximately up to 42 months

    Cohort 1

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

    Time frame: Approximately up to 42 months

    Cohort 1

  7. Time-to-first occurrence of VTE

    Time frame: Approximately up to 42 months

    Cohort 1

  8. Time-to-all-cause mortality

    Time frame: Approximately up to 42 months

    Cohort 1

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

    Time frame: Approximately up to 42 months

    Cohort 1

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

    Time frame: 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)

    Time frame: Approximately up to 42 months

    Cohort 1

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

    Time frame: Approximately up to 42 months

    Cohort 1 and 2

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

    Time frame: Approximately up to 45 months

    Cohort 1 and 2

  14. Severity of TEAEs

    Time frame: Approximately up to 45 months

    Cohort 1 and 2

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

    Time frame: Approximately up to 45 months

    Cohort 1 and 2

  16. Magnitude of ADA to REGN7508 over time

    Time frame: Approximately up to 45 months

    Cohort 1 and 2

  17. Occurrence of ADA to REGN9933 over time

    Time frame: Approximately up to 45 months

    Cohort 1 and 2

  18. Magnitude of ADA to REGN9933 over time

    Time frame: Approximately up to 45 months

    Cohort 1 and 2

  19. Concentrations of REGN7508 over time

    Time frame: Approximately up to 45 months

    Cohort 1 and 2

  20. Concentrations of REGN9933 over time

    Time frame: Approximately up to 45 months

    Cohort 1 and 2

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

    Time frame: Approximately up to week 9

    Cohort 1 and 2

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

    Time frame: Approximately up to week 9

    Cohort 1 and 2

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

    Time frame: Approximately up to 42 months

    Cohort 2

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

    Time frame: 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

    Time frame: Approximately up to 42 months

    Cohort 2

  26. 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

    Time frame: Approximately up to 42 months

    Cohort 2

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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)

Acronym: ROXI-PALISADE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jan 6, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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