REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
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)
Regeneron Pharmaceuticals
2,000 participants
Nov 24, 2025
INTERVENTIONAL
Conditions
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)
Eligibility
Inclusion Criteria2
- Is undergoing a primary elective unilateral TKA
- Is in good health based on laboratory safety testing as described in the protocol
Exclusion Criteria5
- 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
- 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)
- History of thromboembolic disease or thrombophilia
- History of platelet dysfunction
- Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery
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Interventions
Administered per the protocol
Administered per the protocol
Administered per the protocol
Locations(13)
View Full Details on ClinicalTrials.gov
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NCT07213778