RecruitingPhase 3NCT07213778

REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants

A Phase 3, Multicenter, Double-Blinded, Randomized Study to Evaluate REGN7508, a Factor XI Monoclonal Antibody, Versus Acetylsalicylic Acid for Prophylaxis of Symptomatic Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-ASPEN)


Sponsor

Regeneron Pharmaceuticals

Enrollment

2,000 participants

Start Date

Nov 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called Acetylsalicylic Acid (ASA). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery. The aim of the study is to see how effective the study drug is at preventing Venous Thromboembolism (VTE) and other related diseases after total knee replacement surgery compared to acetylsalicylic acid. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Acetylsalicylic Acid (ASA), a drug called Placebo, and others for people with symptomatic venous thromboembolism (vte). The study is currently recruiting participants at 23 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

DRUGAcetylsalicylic Acid (ASA)

Administered per the protocol

DRUGPlacebo

Administered per the protocol


Locations(32)

Horizon Clinical Research

La Mesa, California, United States

Eisenhower Medical Center

Rancho Mirage, California, United States

Sky Ridge Medical Center

Lone Tree, Colorado, United States

South Florida Joint Replacement Center

Deerfield Beach, Florida, United States

Medical Research of Westchester - MPLUS Research Network

Miami, Florida, United States

Phoenix Clinical Research

Tamarac, Florida, United States

Endeavor Health

Skokie, Illinois, United States

The Orthopaedic Research Foundation, Inc.

Indianapolis, Indiana, United States

NextStage Clinical Research, St. Francis Medical Park

Wichita, Kansas, United States

Velocity Clinical Research, Annapolis

Annapolis, Maryland, United States

Sinai Hospital of Baltimore, Inc.

Baltimore, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

University of Rochester Medical Center

Rochester, New York, United States

Eximia Equihealth Research-Raleigh. LLC

Raleigh, North Carolina, United States

The Vein and Vascular Center at Raleigh Radiology

Raleigh, North Carolina, United States

Coastal Vascular Institute, PA

Wilmington, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Ohio Clinical Trials

Columbus, Ohio, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

HD Research - Memorial Hermann Village

Houston, Texas, United States

NextStage Clinical Research, All American Orthopedics and Sports Medicine

Houston, Texas, United States

Flourish Research - San Antonio (Formerly Clinical Trials of Texas)

San Antonio, Texas, United States

Endeavor Clinical Trials

San Antonio, Texas, United States

Carilion Clinic

Roanoke, Virginia, United States

Spokane Joint Replacement Center

Spokane, Washington, United States

Henry Dunant Hospital Center

Athens, Attica, Greece

Sultan Abdul Halim Hospital

Sungai Petani, Kedah, Malaysia

Hospital Tengku Ampuan Afzan (HTTA)

Kuantan, Pahang, Malaysia

PMSI Emergency Medicine Institute

Chisinau, Moldova

View Full Details on ClinicalTrials.gov

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NCT07213778