RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Regeneron Pharmaceuticals • ClinicalTrials.gov ID: NCT07015905

Registry updated: 2026-10-08

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Description

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)

Interventions

REGN7508 (Drug)
Administered per the protocol
Apixaban (Drug)
Administered per the protocol
Enoxaparin (Drug)
Administered per the protocol
Placebo (Drug)
Administered per the protocol

Eligibility criteria

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

Conditions

Venous Thromboembolism (VTE)

Locations

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
Duke University Health System (Duke Health), Duke University Hospital — Durham, North Carolina, 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; South Texas Bone and Joint Institute — 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
Szegedi Tudomanyegyetem; Albert Szent-Gyorgyi Clinical Center — Szeged, Csongrad-Csanad, Hungary
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
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi Uniwersytetu Medycznego w Poznaniu — Poznan, Poland
Arensia Clinics S.R.L — Bucharest, Romania
ARENSIA Exploratory Medicine, County Hospital Cluj-Napoca — Cluj-Napoca, Romania

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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