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NCT07015905PHASE3Recruiting

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

Regeneron Pharmaceuticals

Start Date

6/25/2025

Completion Date

5/12/2027

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)

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 3. Body weight ≤130 kg at screening visit 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 as described in the protocol 3. History of thromboembolic disease or thrombophilia 4. History of major surgery, including brain, spinal, or ocular, or major trauma within approximately the past 6 months prior to randomization 5. Has an estimated Glomerular Filtration Rate (GFR) of \<30 mL/min/1.73 m2 at the screening visit as described in the protocol Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Interventions

DRUG

REGN7508

DRUG

Apixaban

DRUG

Enoxaparin

DRUG

Placebo

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Conditions

Venous Thromboembolism (VTE)

Locations

Shoals Medical Trials, Inc.

Sheffield, Alabama 35660

United States

CARI Clinical Trials

Riverside, California 92504

United States

Denver Metro Orthopedics, P.C. Englewood Location

Englewood, Colorado 80113

United States

Delray Physician Care Center

Delray Beach, Florida 33445

United States

Bioresearch Partner

Miami, Florida 33175

United States

Sacred Heart Health System Inc

Pensacola, Florida 32504

United States

Gulfcoast Research Institute

Sarasota, Florida 34232

United States

Phoenix Clinical Research

Tamarac, Florida 33321

United States

Sinai Hospital of Baltimore, Inc.

Baltimore, Maryland 21215

United States

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

Curalta Clinical Trials

Westwood, New Jersey 07675

United States

Duke University Health System (Duke Health), Duke University Hospital

Durham, North Carolina 27710

United States

Keystone Clinical Studies LLC, dba Flourish Research

Plymouth Meeting, Pennsylvania 19462

United States

HD Research - First Surgical Hospital

Bellaire, Texas 77401

United States

University of Texas (UT); Southwestern Medical Center

Dallas, Texas 75390

United States

NextStage Clinical Research, All American Orthopedics and Sports Medicine

Houston, Texas 77058

United States

Futuro Clinical Trials

McAllen, Texas 78501

United States

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

San Antonio, Texas 78229

United States

DRx Clinical Research, LLC; South Texas Bone and Joint Institute

San Antonio, Texas 78249

United States

DRx Clinical Research, LLC

St. George, Utah 84770

United States

Multi-profile Hospital for Active Treatment Hearth and Brain EAD

Pleven, 5804

Bulgaria

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

Sofia, 1404

Bulgaria

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

Stara Zagora, 6003

Bulgaria

Szegedi Tudomanyegyetem; Albert Szent-Gyorgyi Clinical Center

Szeged, Csongrad-Csanad 6725

Hungary

Gyor-Moson-Sopron Varmegyei Egyetemi Oktato Korhaz

Győr, Győr-Moson-Sopron 9024

Hungary

University of Debrecen

Debrecen, Hajdú-Bihar 4031

Hungary

Semmelweis University

Budapest, 1082

Hungary

Kansai Rosai Hospital

Amagasaki-shi, Hyōgo 660-8511

Japan

Yuuai Medical Center

Tomigusuku, Okinawa 901-0224

Japan

National Hospital Organization Osaka Minami Medical Center

Kawachi-Nagano, Osaka 586-8521

Japan

Osaka Saiseikai Nakatsu Hospital

Kita-Ku, Osaka 530-0012

Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo 113-8431

Japan

Saga University Hospital

Saga, 849-8501

Japan

Liepajas regionala slimnica; SIA

Liepāja, LV-3414

Latvia

Rigas 2 slimnica, SIA

Riga, LV-1004

Latvia

Hospital of Traumatology and Orthopaedics

Riga, LV-1005

Latvia

ORTO Klinika

Riga, LV-1005

Latvia

Vidzemes slimnica

Valmiera, LV-4201

Latvia

Lietuvos sveikatos mokslu universiteto Kauno ligonine

Kaunas, LT-47144

Lithuania

Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik

Kaunas, LT-50161

Lithuania

Vsi Klaipedos Universitetine Ligonine

Klaipėda, LT-92288

Lithuania

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

Krakow, 31-826

Poland

Uniwersytecki Szpital Kliniczny nr.2 Uniwersytetu Medycznego w Lodzi

Lodz, 90-549

Poland

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

Lodz, 92-213

Poland

Arensia Clinics S.R.L

Bucharest, 011658

Romania

ARENSIA Exploratory Medicine, County Hospital Cluj-Napoca

Cluj-Napoca, 400006

Romania