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A Study of REGN7544 for the Treatment in Adult Patients With Sepsis-Induced Hypotension
Sponsor: Regeneron Pharmaceuticals
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
Conditions
Interventions
REGN7544
Administered per the protocol
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