NCT06299111

A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC)

A Master Protocol for a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of REGN9933 and REGN7508, Monoclonal Antibodies Against Factor XI for Prevention of Venous Thromboembolism in Patients With a Peripherally Inserted Central Catheter (ROXI-CATH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is researching 2 different experimental drugs called REGN9933 and REGN7508 (called "study drugs"). The study is focused on adults undergoing a placement of a catheter in the vein, also called a 'PICC line'. The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related disease after catheter placement. 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)

Conditions

• Venous Thromboembolism

Interventions

Type	Name	Description
DRUG	REGN9933	Intravenous (IV) single dose administered
DRUG	REGN7508	IV single dose administered
DRUG	Placebo	IV single dose administered

Timeline

• Start date: 2024-09-20
• Primary completion: 2026-03-27
• Completion: 2026-03-27
• First posted: 2024-03-07
• Last updated: 2026-04-13

Locations

23 sites across 6 countries: United States, Bulgaria, Canada, Israel, Romania, United Kingdom

Regulatory

• FDA-regulated drug study