Status:
RECRUITING
A Study of REGN7544 for the Treatment in Adult Patients With Sepsis-Induced Hypotension
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Sepsis-Induced Hypotension
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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") ...
Eligibility Criteria
Inclusion
- Key
- Proven or suspected infection defined as administration or planned administration of antimicrobial therapy within the screening period
- 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
- Key
Exclusion
- Unable to obtain informed consent by participant or Legally Authorized Representative (LAR)
- Clinical status requires vasopressor and/or Blood Pressure (BP) management inconsistent with the study protocol
- Primary cause of hypotension suspected to be due to non-sepsis cause (eg, hemorrhage, burns, or cardiogenic shock), including shock after cardiac arrest
- Ejection fraction \<20% in the most recent known echocardiogram
- Acute coronary syndrome based on clinical symptoms and/or electrocardiogram (ECG) during hospitalization
- 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
- Any prior diagnosis of severe pulmonary hypertension, as defined in the protocol
- 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
- 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
Key Trial Info
Start Date :
May 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 19 2026
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06608901
Start Date
May 5 2025
End Date
October 19 2026
Last Update
January 7 2026
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Arizona
Tucson, Arizona, United States, 85724
2
Yale University
New Haven, Connecticut, United States, 06510
3
Emory University Hospital
Atlanta, Georgia, United States, 30322
4
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287