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Purpose

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)

Condition

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Proven or suspected infection defined as administration or planned administration of antimicrobial therapy within the screening period 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

Exclusion Criteria

  1. Unable to obtain informed consent by participant or Legally Authorized Representative (LAR) 2. Clinical status requires vasopressor and/or Blood Pressure (BP) management inconsistent with the study protocol 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. Ejection fraction <20% in the most recent known echocardiogram 5. Acute coronary syndrome based on clinical symptoms and/or electrocardiogram (ECG) during hospitalization 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. Any prior diagnosis of severe pulmonary hypertension, as defined in the protocol 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. Received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia NOTE: Other Protocol-Defined Inclusion-Exclusion Criteria Apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
REGN7544
  • Drug: REGN7544
    Administered per the protocol
Placebo Comparator
Placebo (PB)
  • Drug: PB
    Administered per the protocol

Recruiting Locations

University of Arizona
Tucson 5318313, Arizona 5551752 85724

Yale University
New Haven 4839366, Connecticut 4831725 06510

Emory University Hospital
Atlanta 4180439, Georgia 4197000 30322

Johns Hopkins Hospital
Baltimore 4347778, Maryland 4361885 21287

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114

Harvard Medical School - Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215

New York University Langone Health Brooklyn Hospital
Brooklyn 5110302, New York 5128638 11220

Bellevue Hospital
New York 5128581, New York 5128638 10016

New York University Langone Health Tisch-Kimmel Hospital
New York 5128581, New York 5128638 10016

Montefiore Medical Center - Weiler Hospital
The Bronx 5110266, New York 5128638 10461

Montefiore Medical Center - Moses Campus
The Bronx 5110266, New York 5128638 10467

Atrium Health
Winston-Salem 4499612, North Carolina 4482348 27157

Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44195

MUSC SCTR Research Nexus Clinic and Lab
Charleston 4574324, South Carolina 4597040 29425

Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232

Intermountain Medical Center - Murray (Pulmonary Medicine)
Murray 5778755, Utah 5549030 84107

More Details

Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.