Phase 3 Trial Comparing REGN7508 to Apixaban and Enoxaparin for Preventing Blood Clots After Elective Knee Replacement Surgery in Adults

What this Trial Is About

Researchers are evaluating an experimental drug called REGN7508 in adults undergoing elective, unilateral total knee replacement surgery. The study aims to assess how well REGN7508 prevents venous thromboembolism VTE and related conditions following surgery. It also investigates potential side effects, the levels of the drug in the blood over time, and the bodys antibody response to the drug. Participants in this phase 3 trial receive one of several treatments REGN7508 alone, REGN7508 with placebo, apixaban, or enoxaparin, all administered according to protocol. The study uses a randomized, parallel design with double blinding to compare these treatments. The treatment period focuses on the first 12 days after surgery, with extended monitoring up to approximately 90 days to assess drug concentration and antibody formation. During the study, participants will undergo assessments including monitoring for symptomatic and asymptomatic VTE events, bleeding incidents, and adverse events up to day 90. Blood tests will measure drug levels and antibodies against REGN7508. Safety and effectiveness outcomes are tracked closely with visits approximately 14 days post-surgery for primary measures and follow-up assessments around day 90. Total participation lasts through the treatment and extended safety evaluation period.

REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults