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)
Regeneron Pharmaceuticals
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 thrombo…
Interventions
- DrugREGN7508
Administered per the protocol
- DrugApixaban
Administered per the protocol
- DrugEnoxaparin
Administered per the protocol
- DrugPlacebo
Administered per the protocol
Locations (44)
- Shoals Medical Trials, Inc.Sheffield, Alabama
- CARI Clinical TrialsRiverside, California
- Denver Metro Orthopedics, P.C. Englewood LocationEnglewood, Colorado
- Delray Physician Care CenterDelray Beach, Florida
- Bioresearch PartnerMiami, Florida
- Sacred Heart Health System IncPensacola, Florida