RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-05-05
Study Completion:2026-10-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06608901

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Proven or suspected infection defined as administration or planned administration of antimicrobial therapy within the screening period
  2. 2. Sepsis-induced hypotension that has not responded to Intravenous (IV) fluids, receiving 1 or 2 vasopressors and maintaining a Mean Arterial Pressure (MAP) of ≥ 65 mm Hg for at least 2 consecutive hours immediately prior to randomization, as defined in the protocol
  1. 1. Unable to obtain informed consent by participant or Legally Authorized Representative (LAR)
  2. 2. Clinical status requires vasopressor and/or Blood Pressure (BP) management inconsistent with the study protocol
  3. 3. Primary cause of hypotension suspected to be due to non-sepsis cause (eg, hemorrhage, burns, or cardiogenic shock), including shock after cardiac arrest
  4. 4. Ejection fraction \<20% in the most recent known echocardiogram
  5. 5. Acute coronary syndrome based on clinical symptoms and/or electrocardiogram (ECG) during hospitalization
  6. 6. History of hospitalization due to heart failure, myocardial infarction, stroke, clinically significant ventricular arrhythmia, transient ischemic attack, or unstable angina within the preceding 3 months
  7. 7. Any prior diagnosis of severe pulmonary hypertension, as defined in the protocol
  8. 8. Receiving 3 or more vasopressors or exceeding the maximal combined dose as defined in the protocol, during the screening period or at the time of study drug administration
  9. 9. Received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia

Contacts and Locations

Study Contact

Clinical Trials Administrator
CONTACT
844-734-6643
clinicaltrials@regeneron.com

Principal Investigator

Clinical Trial Management
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

Yale University
New Haven, Connecticut, 06510
United States
Emory University Hospital
Atlanta, Georgia, 30322
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Harvard Medical School - Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Atrium Health
Winston-Salem, North Carolina, 27157
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Intermountain Medical Center - Murray (Pulmonary Medicine)
Murray, Utah, 84107
United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

  • Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-05
Study Completion Date2026-10-19

Study Record Updates

Study Start Date2025-05-05
Study Completion Date2026-10-19

Terms related to this study

Keywords Provided by Researchers

  • Natriuretic Peptide Receptor 1 (NPR1)
  • Low Blood Pressure

Additional Relevant MeSH Terms

  • Sepsis-Induced Hypotension