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NOT YET RECRUITING
NCT07876492
PHASE3

A Study to Evaluate Cenvacibart (REGN7508) for Secondary Stroke Prevention in Adult Participants

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will test an experimental Regeneron drug called cenvacibart (REGN7508) ("study drug") compared with a placebo (a look-alike treatment with no active medicine) on top of background antiplatelet medications. The purpose of this study is to find out if cenvacibart can safely reduce the risk of another ischemic stroke or another blood clot related events in people who have recently had an ischemic stroke or mini-stroke (TIA). The study is looking at: * How well cenvacibart works * What side effects cenvacibart might cause * How much cenvacibart is in the blood at different times * How the body reacts to cenvacibart * How cenvacibart could affect the blood which can help researchers understand why cenvacibart works better in some people than others

Official title: A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate Cenvacibart (REGN7508), a Monoclonal Antibody Against Factor XI, for Secondary Stroke Prevention (ROXI-DAISEN)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

6106

Start Date

2026-11-20

Completion Date

2029-12-15

Last Updated

2026-10-15

Healthy Volunteers

No

Interventions

DRUG

Cenvacibart

Administered per the protocol

DRUG

Placebo

Administered per the protocol