REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants

NCT07213778 · tracked via the Priya Life Science USA tracker

Sponsor

Regeneron Pharmaceuticals

Phase

Phase 3

Started

2025-11-24

Last updated

2026-09-14

Condition(s) studied

Symptomatic Venous Thromboembolism (VTE)

Investigational drug(s) / intervention(s)

REGN7508 →Acetylsalicylic Acid (ASA)Placebo

REGN7508: Administered per the protocol

Acetylsalicylic Acid (ASA): Administered per the protocol

Placebo: Administered per the protocol

Study summary

This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called Acetylsalicylic Acid (ASA). 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 compared to acetylsalicylic acid.

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 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; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis (eg, hemophilia A or B, von Willebrand's Factor deficiency) 3. History of thromboembolic disease or thrombophilia 4. History of platelet dysfunction 5. Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Primary outcome measure(s)

Incidence of the composite endpoint of symptomatic VTE and all-cause death — Through day 30 visit

Trial sites (36)

Facility	City	Region	Status
Horizon Clinical Research	La Mesa	California	Recruiting
Eisenhower Medical Center	Rancho Mirage	California	Recruiting
Sky Ridge Medical Center	Lone Tree	Colorado	Recruiting
South Florida Joint Replacement Center	Deerfield Beach	Florida	Recruiting
Medical Research of Westchester - MPLUS Research Network	Miami	Florida	Recruiting
Larkin Community Hospital South Miami	South Miami	Florida	Recruiting
Phoenix Clinical Research	Tamarac	Florida	Recruiting
Endeavor Health	Skokie	Illinois	Recruiting
The Orthopaedic Research Foundation, Inc.	Indianapolis	Indiana	Recruiting
NextStage Clinical Research, St. Francis Medical Park	Wichita	Kansas	Recruiting
Velocity Clinical Research, Annapolis	Annapolis	Maryland	Recruiting
Sinai Hospital of Baltimore, Inc.	Baltimore	Maryland	Recruiting
Tufts Medical Center	Boston	Massachusetts	Recruiting
Boston Medical Center	Boston	Massachusetts	Recruiting
Holy Name Medical Center	Teaneck	New Jersey	Recruiting
University of Rochester Medical Center	Rochester	New York	Recruiting
Duke University Health System (Duke Health), Duke University Hospital	Durham	North Carolina	Recruiting
Eximia Equihealth Research-Raleigh. LLC	Raleigh	North Carolina	Recruiting
The Vein and Vascular Center at Raleigh Radiology	Raleigh	North Carolina	Recruiting
Coastal Vascular Institute, PA	Wilmington	North Carolina	Recruiting
University of Cincinnati	Cincinnati	Ohio	Recruiting
The Ohio State University Wexner Medical Center	Columbus	Ohio	Recruiting
Ohio Clinical Trials	Columbus	Ohio	Recruiting
University of Pittsburgh	Pittsburgh	Pennsylvania	Recruiting
HD Research - Memorial Hermann Village	Houston	Texas	Completed
NextStage Clinical Research, All American Orthopedics and Sports Medicine	Houston	Texas	Recruiting
Flourish Research - San Antonio (Formerly Clinical Trials of Texas)	San Antonio	Texas	Recruiting
Endeavor Clinical Trials	San Antonio	Texas	Withdrawn
Carilion Clinic	Roanoke	Virginia	Recruiting
Spokane Joint Replacement Center	Spokane	Washington	Recruiting
Henry Dunant Hospital Center	Athens	Attica	Recruiting
Sultan Abdul Halim Hospital	Sungai Petani	Kedah	Recruiting
Hospital Pakar Universiti Sains Malaysia	Kota Bharu	Kelantan	Recruiting
Hospital Tengku Ampuan Afzan (HTTA)	Kuantan	Pahang	Recruiting
Hospital Queen Elizabeth II	Kota Kinabalu	Sabah	Recruiting
PMSI Emergency Medicine Institute	Chisinau	Moldova	Recruiting

More Regeneron Pharmaceuticals trials in the USA

A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment Enrolling by invitation

A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma Recruiting

A Safety and Efficacy Long-Term Follow-up Study of Adult Participants Treated With Gene Modified T Cells Recruiting

A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer Active, not recruiting

Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH) 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 NCT07213778 on ClinicalTrials.gov ↗ ← All trials in the USA