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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)
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)
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
June 25, 2025
Primary Completion Date
February 20, 2027
Completion Date
May 12, 2027
Last Updated
March 9, 2026
2,000
ESTIMATED participants
REGN7508
DRUG
Apixaban
DRUG
Enoxaparin
DRUG
Placebo
DRUG
Lead Sponsor
Regeneron Pharmaceuticals
NCT07310693
NCT07288632
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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