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

NCT07015905 · tracked via the Priya Life Science USA tracker

Sponsor

Regeneron Pharmaceuticals

Phase

Phase 3

Started

2025-06-25

Last updated

2026-09-15

Condition(s) studied

Venous Thromboembolism (VTE)

Investigational drug(s) / intervention(s)

REGN7508ApixabanEnoxaparinPlacebo

REGN7508: Administered per the protocol

Apixaban: Administered per the protocol

Enoxaparin: Administered per the protocol

Placebo: Administered per the protocol

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death] — Through day 12 visit, approximately 14 days

Trial sites (47)

Facility	City	Region	Status
Shoals Medical Trials, Inc.	Sheffield	Alabama	Recruiting
CARI Clinical Trials	Riverside	California	Recruiting
Denver Metro Orthopedics, P.C. Englewood Location	Englewood	Colorado	Recruiting
Delray Physician Care Center	Delray Beach	Florida	Recruiting
Bioresearch Partner	Miami	Florida	Recruiting
Sacred Heart Health System Inc	Pensacola	Florida	Recruiting
Gulfcoast Research Institute	Sarasota	Florida	Recruiting
Phoenix Clinical Research	Tamarac	Florida	Recruiting
Sinai Hospital of Baltimore, Inc.	Baltimore	Maryland	Recruiting
Brigham and Women's Hospital	Boston	Massachusetts	Recruiting
Curalta Clinical Trials	Westwood	New Jersey	Recruiting
Duke University Health System (Duke Health), Duke University Hospital	Durham	North Carolina	Recruiting
Keystone Clinical Studies LLC, dba Flourish Research	Plymouth Meeting	Pennsylvania	Recruiting
HD Research - First Surgical Hospital	Bellaire	Texas	Recruiting
University of Texas (UT); Southwestern Medical Center	Dallas	Texas	Recruiting
NextStage Clinical Research, All American Orthopedics and Sports Medicine	Houston	Texas	Recruiting
Futuro Clinical Trials	McAllen	Texas	Recruiting
Flourish Research - San Antonio (Formerly Clinical Trials of Texas)	San Antonio	Texas	Recruiting
DRx Clinical Research, LLC; South Texas Bone and Joint Institute	San Antonio	Texas	Recruiting
DRx Clinical Research, LLC	St. George	Utah	Recruiting
Multi-profile Hospital for Active Treatment Hearth and Brain EAD	Pleven	Bulgaria	Recruiting
Multiprofile Hospital for Active Treatment; Sveta Sofia EOOD (MBAL Sveta Sofia),	Sofia	Bulgaria	Recruiting
University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich"	Stara Zagora	Bulgaria	Recruiting
Szegedi Tudomanyegyetem; Albert Szent-Gyorgyi Clinical Center	Szeged	Csongrad-Csanad	Recruiting
Gyor-Moson-Sopron Varmegyei Egyetemi Oktato Korhaz	Győr	Győr-Moson-Sopron	Recruiting
University of Debrecen	Debrecen	Hajdú-Bihar	Recruiting
Semmelweis University	Budapest	Hungary	Recruiting
Kansai Rosai Hospital	Amagasaki-shi	Hyōgo	Recruiting
Yuuai Medical Center	Tomigusuku	Okinawa	Recruiting
National Hospital Organization Osaka Minami Medical Center	Kawachi-Nagano	Osaka	Recruiting
Osaka Saiseikai Nakatsu Hospital	Kita-Ku	Osaka	Recruiting
Juntendo University Hospital	Bunkyo-ku	Tokyo	Recruiting
Saga University Hospital	Saga	Japan	Recruiting
Liepajas regionala slimnica; SIA	Liepāja	Latvia	Recruiting
Rigas 2 slimnica, SIA	Riga	Latvia	Recruiting
Hospital of Traumatology and Orthopaedics	Riga	Latvia	Recruiting
ORTO Klinika	Riga	Latvia	Recruiting
Vidzemes slimnica	Valmiera	Latvia	Recruiting
Lietuvos sveikatos mokslu universiteto Kauno ligonine	Kaunas	Lithuania	Recruiting
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik	Kaunas	Lithuania	Recruiting

+ 7 more sites — see the full list on the official registry below.

On this site

📄 Eliquis (apixaban) drug profile →

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Other trials for the same condition

Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07015905 on ClinicalTrials.gov ↗ ← All trials in the USA