NCT06454630

A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants

A Phase 2, Multicenter, Randomized, Open-Label, Active Control Study of REGN7508, a Factor XI Monoclonal Antibody, for Prevention of Venous Thromboembolism After Elective, Unilateral, Total Knee Arthroplasty (ROXI-VTE II)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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 (TKR) 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 unilateral 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 drug less effective or could lead to side effects)

Conditions

• Venous Thromboembolism

Interventions

Type	Name	Description
DRUG	REGN7508	Administered by single intravenous (IV) dose
DRUG	Enoxaparin	Administered by subcutaneous (SC) dose daily through the time of venography (or day 12, whichever is earlier)

Timeline

• Start date: 2024-06-27
• Primary completion: 2024-11-19
• Completion: 2025-01-21
• First posted: 2024-06-12
• Last updated: 2026-03-02
• Results posted: 2026-03-02

Locations

14 sites across 5 countries: Bulgaria, Hungary, Latvia, Lithuania, Poland

Regulatory

• FDA-regulated drug study