A Study of REGN7544 for the Treatment in Adult Patients With Sepsis-Induced Hypotension
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
- Sepsis-Induced Hypotension
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental REGN7544 |
|
|
|
Placebo Comparator Placebo (PB) |
|
Recruiting Locations
Tucson 5318313, Arizona 5551752 85724
New Haven 4839366, Connecticut 4831725 06510
Atlanta 4180439, Georgia 4197000 30322
Baltimore 4347778, Maryland 4361885 21287
Boston 4930956, Massachusetts 6254926 02114
Boston 4930956, Massachusetts 6254926 02215
Brooklyn 5110302, New York 5128638 11220
New York 5128581, New York 5128638 10016
New York 5128581, New York 5128638 10016
The Bronx 5110266, New York 5128638 10461
The Bronx 5110266, New York 5128638 10467
Winston-Salem 4499612, North Carolina 4482348 27157
Cleveland 5150529, Ohio 5165418 44195
Charleston 4574324, South Carolina 4597040 29425
Nashville 4644585, Tennessee 4662168 37232
Murray 5778755, Utah 5549030 84107
More Details
- Status
- Recruiting
- Sponsor
- Regeneron Pharmaceuticals