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RECRUITING
NCT07015905
PHASE3

REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study is researching an experimental drug called REGN7508 (called "study drug"). 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. 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)

Official title: A Phase 3, Multicenter, Randomized, Open-Label, Study to Evaluate REGN7508, A Factor XI Monoclonal Antibody, Versus Apixaban and Enoxaparin for Prophylaxis of Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-APEX)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2025-06-25

Completion Date

2027-05-12

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

REGN7508

Administered per the protocol

DRUG

Apixaban

Administered per the protocol

DRUG

Enoxaparin

Administered per the protocol

DRUG

Placebo

Administered per the protocol

Locations (41)

Shoals Medical Trials, Inc.

Sheffield, Alabama, United States

CARI Clinical Trials

Riverside, California, United States

Denver Metro Orthopedics, P.C. Englewood Location

Englewood, Colorado, United States

Delray Physician Care Center

Delray Beach, Florida, United States

Bioresearch Partner

Miami, Florida, United States

Sacred Heart Health System Inc

Pensacola, Florida, United States

Gulfcoast Research Institute

Sarasota, Florida, United States

Phoenix Clinical Research

Tamarac, Florida, United States

Sinai Hospital of Baltimore, Inc.

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Curalta Clinical Trials

Westwood, New Jersey, United States

Keystone Clinical Studies LLC, dba Flourish Research

Plymouth Meeting, Pennsylvania, United States

HD Research - First Surgical Hospital

Bellaire, Texas, United States

University of Texas (UT); Southwestern Medical Center

Dallas, Texas, United States

NextStage Clinical Research, All American Orthopedics and Sports Medicine

Houston, Texas, United States

Futuro Clinical Trials

McAllen, Texas, United States

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

San Antonio, Texas, United States

DRx Clinical Research, LLC

St. George, Utah, United States

Multi-profile Hospital for Active Treatment Hearth and Brain EAD

Pleven, Bulgaria

Multiprofile Hospital for Active Treatment; Sveta Sofia EOOD (MBAL Sveta Sofia),

Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich"

Stara Zagora, Bulgaria

Gyor-Moson-Sopron Varmegyei Egyetemi Oktato Korhaz

Győr, Győr-Moson-Sopron, Hungary

University of Debrecen

Debrecen, Hajdú-Bihar, Hungary

Semmelweis University

Budapest, Hungary

Kansai Rosai Hospital

Amagasaki-shi, Hyōgo, Japan

Yuuai Medical Center

Tomigusuku, Okinawa, Japan

National Hospital Organization Osaka Minami Medical Center

Kawachi-Nagano, Osaka, Japan

Osaka Saiseikai Nakatsu Hospital

Kita-Ku, Osaka, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Saga University Hospital

Saga, Japan

Liepajas regionala slimnica; SIA

Liepāja, Latvia

Rigas 2 slimnica, SIA

Riga, Latvia

Hospital of Traumatology and Orthopaedics

Riga, Latvia

ORTO Klinika

Riga, Latvia

Vidzemes slimnica

Valmiera, Latvia

Lietuvos sveikatos mokslu universiteto Kauno ligonine

Kaunas, Lithuania

Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik

Kaunas, Lithuania

Vsi Klaipedos Universitetine Ligonine

Klaipėda, Lithuania

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. z o.o.

Krakow, Poland

Uniwersytecki Szpital Kliniczny nr.2 Uniwersytetu Medycznego w Lodzi

Lodz, Poland

Samodzieny Publiczny Zaklad Opieki Zdorowotne (SP ZOZ) Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi - Hematology

Lodz, Poland