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

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)

Timeline

Start

2024-06-27

Primary completion

2024-11-19

Completion

2025-01-21

Outcome

Met primary endpoint

paper REGN7508Cat was superior to enoxaparin for venous thromboembolism prevention; PMID 41218619 ↗

paper For REGN7508Cat versus the combined enoxaparin groups, the mean aOR was 0·37 (0·20-0·68); the posterior probability was 99·8%. PMID 41218619 ↗

Publications

• Weitz JI, Kithcart AP, O'Brien MP, Levy O, Marin E, Onisko M, Mohammadi KA, Li D, Meagher KA, Chang HH, Olenchock BA, Gutstein DE, Segers A, Roberts RS, Bonaca MP, Raskob GE. Efficacy and safety of REGN9933A2 and REGN7508Cat for preventing postoperative venous thromboembolism (ROXI-VTE-I and ROXI-VTE-II): two randomised, open-label, phase 2 trials. Lancet. 2025 Nov 29;406(10519):2551-2563. doi: 10.1016/S0140-6736(25)02097-5. Epub 2025 Nov 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Enoxaparin sodium	Other / unclassified	40 mg	Subcutaneous
Subject	REGN7508	Monoclonal antibody	250 mg	Intravenous

Indications