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RECRUITING
NCT07213778
PHASE3

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

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study is researching an experimental drug called REGN7508 versus Acetylsalicylic Acid (ASA) (each 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 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)

Official title: A Phase 3, Multicenter, Double-Blinded, Randomized Study to Evaluate REGN7508, a Factor XI Monoclonal Antibody, Versus Acetylsalicylic Acid for Prophylaxis of Symptomatic Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-ASPEN)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2025-11-24

Completion Date

2027-07-16

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

REGN7508

Administered per the protocol

DRUG

Acetylsalicylic Acid (ASA)

Administered per the protocol

DRUG

Placebo

Administered per the protocol

Locations (13)

Eisenhower Medical Center

Rancho Mirage, California, United States

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Medical Research of Westchester - MPLUS Research Network

Miami, Florida, United States

Phoenix Clinical Research

Tamarac, Florida, United States

NextStage Clinical Research, St. Francis Medical Park

Wichita, Kansas, United States

Sinai Hospital of Baltimore, Inc.

Baltimore, Maryland, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

Coastal Vascular Institute, PA

Wilmington, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Ohio Clinical Trials

Columbus, Ohio, United States

HD Research - Memorial Hermann Village

Houston, Texas, United States

Endeavor Clinical Trials

San Antonio, Texas, United States

Spokane Joint Replacement Center

Spokane, Washington, United States