RecruitingPhase 3NCT07318610

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

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)


Sponsor

Regeneron Pharmaceuticals

Enrollment

7,050 participants

Start Date

Jul 30, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo, a drug called REGN7508, and others for people with peripheral artery disease (pad). The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGREGN7508

Administered per the protocol

DRUGREGN9933

Administered per the protocol

DRUGPlacebo

Administered per the protocol

DRUGRivaroxaban

Administered per the protocol


Locations(9)

Lake Martin Medical and Vascular Center

Alexander City, Alabama, United States

Axsendo Clinical Research, Integrated Medical Services

Avondale, Arizona, United States

Applied Research Center of Arkansas

Little Rock, Arkansas, United States

Nature Coast Clinical Research - Cardiology

Crystal River, Florida, United States

Cardiovascular Solutions

Shreveport, Louisiana, United States

Apex Research Foundation, LLC

Jackson, Tennessee, United States

PharmaTex Research

Amarillo, Texas, United States

Epic Medical Research

DeSoto, Texas, United States

Epic Medical Research-Plano

Plano, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07318610


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