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REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Sponsor: Regeneron Pharmaceuticals
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
Conditions
Interventions
REGN7508
Administered per the protocol
Apixaban
Administered per the protocol
Enoxaparin
Administered per the protocol
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