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ACTIVE NOT RECRUITING
NCT06608901
PHASE2

A Study of REGN7544 for the Treatment in Adult Patients With Sepsis-Induced Hypotension

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study is researching an experimental drug called REGN7544 (called "study drug"). The study is focused on adult patients (18 to 85 years) hospitalized due to a serious infection (called "sepsis") and receiving standard-of-care medications for low blood pressure (called "vasopressors") due to sepsis. The aim of the study is to see how safe, tolerable, and effective the study drug is by observing the effects on blood pressure and the total amount of vasopressor dose received during the stay in the hospital. The study is looking at several other research questions, including: * How the study drug changes the blood pressure and the amount of intravenous (IV) fluids given to participants with low blood pressure due to sepsis * 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)

Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN7544, an Antagonist Monoclonal Antibody to NPR1, in Patients With Sepsis-Induced Hypotension

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

76

Start Date

2025-05-05

Completion Date

2026-04-30

Last Updated

2026-02-13

Healthy Volunteers

No

Interventions

DRUG

REGN7544

Administered per the protocol

DRUG

PB

Administered per the protocol

Locations (29)

University of Arizona

Tucson, Arizona, United States

Yale University

New Haven, Connecticut, United States

Emory University Hospital

Atlanta, Georgia, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Harvard Medical School - Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

New York University Langone Health Brooklyn Hospital

Brooklyn, New York, United States

Bellevue Hospital

New York, New York, United States

New York University Langone Health Tisch-Kimmel Hospital

New York, New York, United States

Montefiore Medical Center - Weiler Hospital

The Bronx, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Atrium Health

Winston-Salem, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

MUSC SCTR Research Nexus Clinic and Lab

Charleston, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Intermountain Medical Center - Murray (Pulmonary Medicine)

Murray, Utah, United States

Centre Hospitalier Regional Universaitaire de Tours (CHRU de Tours)

Tours, Centre-Val de Loire, France

CHU Dupuytren

Limoges, Nouvelle-Aquitaine, France

Centre Hospitalier Le Mans

Le Mans, Pays de la Loire Region, France

Centre Hospitalier Departemental (CHD) Vendee

La Roche-sur-Yon, Vendee, France

Centre Hospitalier Universitaire Angers

Angers, France

Raymond Poincare University Hospital

Garches, France

Paris-Saclay University Hospitals

Le Kremlin-Bicêtre, France

CHU Nantes

Nantes, France

Centre Hospitalier Universitaire d'Orleans

Orléans, France

CHU de Reims Hopital Robert Debre

Reims, France

Hopitaux Universitaires de Strasbourg

Strasbourg, France

Hopital Nord Franche Comte

Trévenans, France

Hopital Cochin

Paris, Île-de-France Region, France