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NCT07213778PHASE3Recruiting

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

Regeneron Pharmaceuticals

Start Date

11/24/2025

Completion Date

7/16/2027

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 Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: 1. Is undergoing a primary elective unilateral TKA 2. Is in good health based on laboratory safety testing as described in the protocol Key Exclusion Criteria: 1. Any condition that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant by study participation 2. History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis (eg, hemophilia A or B, von Willebrand's Factor deficiency) 3. History of thromboembolic disease or thrombophilia 4. History of platelet dysfunction 5. Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Interventions

DRUG

REGN7508

DRUG

Acetylsalicylic Acid (ASA)

DRUG

Placebo

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Conditions

Symptomatic Venous Thromboembolism (VTE)

Locations

Horizon Clinical Research

La Mesa, California 91942

United States

Eisenhower Medical Center

Rancho Mirage, California 92270

United States

Sky Ridge Medical Center

Lone Tree, Colorado 80124

United States

South Florida Joint Replacement Center

Deerfield Beach, Florida 33064

United States

Medical Research of Westchester - MPLUS Research Network

Miami, Florida 33165

United States

Phoenix Clinical Research

Tamarac, Florida 33321

United States

Endeavor Health

Skokie, Illinois 60076

United States

The Orthopaedic Research Foundation, Inc.

Indianapolis, Indiana 46278

United States

NextStage Clinical Research, St. Francis Medical Park

Wichita, Kansas 67214

United States

Velocity Clinical Research, Annapolis

Annapolis, Maryland 21401

United States

Sinai Hospital of Baltimore, Inc.

Baltimore, Maryland 21215

United States

Tufts Medical Center

Boston, Massachusetts 02111

United States

Boston Medical Center

Boston, Massachusetts 02118

United States

Holy Name Medical Center

Teaneck, New Jersey 07666

United States

University of Rochester Medical Center

Rochester, New York 14623-5863

United States

Eximia Equihealth Research-Raleigh. LLC

Raleigh, North Carolina 27612

United States

The Vein and Vascular Center at Raleigh Radiology

Raleigh, North Carolina 27612

United States

Coastal Vascular Institute, PA

Wilmington, North Carolina 28401

United States

University of Cincinnati

Cincinnati, Ohio 45267

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio 43210

United States

Ohio Clinical Trials

Columbus, Ohio 43212

United States

University of Pittsburgh

Pittsburgh, Pennsylvania 15213-3108

United States

HD Research - Memorial Hermann Village

Houston, Texas 77043

United States

NextStage Clinical Research, All American Orthopedics and Sports Medicine

Houston, Texas 77058

United States

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

San Antonio, Texas 78229

United States

Endeavor Clinical Trials

San Antonio, Texas 78240

United States

Carilion Clinic

Roanoke, Virginia 24015

United States

Spokane Joint Replacement Center

Spokane, Washington 99218

United States

Henry Dunant Hospital Center

Athens, Attica 11526

Greece

Sultan Abdul Halim Hospital

Sungai Petani, Kedah 08000

Malaysia

Hospital Tengku Ampuan Afzan (HTTA)

Kuantan, Pahang 25100

Malaysia

PMSI Emergency Medicine Institute

Chisinau, MD-2004

Moldova