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") 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)
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)
Brief Title
A Study of REGN7544 for the Treatment in Adult Patients With Sepsis-Induced Hypotension
Central Contacts
Central Contact Role
Contact
Central Contact Phone
844-734-6643
Central Contact Email
clinicaltrials@regeneron.com
Completion Date
Completion Date Type
Estimated
Conditions
Sepsis-Induced Hypotension
Eligibility Criteria
Key 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
Key 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
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
Key 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
Inclusion Criteria
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
Inclusion-
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
Inclusion-
Gender
All
Gender Based
false
Keywords
Natriuretic Peptide Receptor 1 (NPR1)
Low Blood Pressure
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
85 Years
Minimum Age
18 Years
NCT Id
NCT06608901
Org Class
Industry
Org Full Name
Regeneron Pharmaceuticals
Org Study Id
R7544-SIH-2435
Overall Status
Recruiting
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome Measure
Cumulative vasopressor dose
Outcome Time Frame
Through 72 Hours
Secondary Ids
Secondary Id
2024-514946-35-00
Secondary Outcomes
Outcome Time Frame
Through 90 Days
Outcome Measure
Occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 and higher Treatment-Emergent Adverse Events (TEAEs)
Outcome Time Frame
Baseline Over 4 Hours
Outcome Measure
Time-weighted average Mean Arterial Pressure (MAP)
Outcome Time Frame
Baseline, At 4 Hours
Outcome Measure
Change in MAP
Outcome Time Frame
At 24, 48 and 72 Hours
Outcome Measure
Proportion of surviving participants free of vasopressor(s)
Outcome Time Frame
Through 72 Hours
Outcome Measure
Cumulative net fluid balance
Outcome Time Frame
Through 72 Hours
Outcome Measure
Cumulative urine output
Outcome Time Frame
Through 72 Hours
Outcome Measure
Cumulative fluid intake
Outcome Time Frame
Through 90 Days
Outcome Measure
Concentrations of REGN7544 in serum
Outcome Time Frame
Through 90 Days
Outcome Measure
Incidence of Anti-Drug Antibodies (ADA) to REGN7544
Outcome Time Frame
Through 90 Days
Outcome Measure
Magnitude of ADA to REGN7544
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
85
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ari Moskowitz
Investigator Email
amoskowitz@montefiore.org
Investigator Department
Medicine
Investigator Division
Critical Care
Study Department
Medicine
Study Division
Critical Care Medicine
Categories Mesh Debug
Blood & Bone Marrow Cancers --- VASCULAR DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
MeSH Terms
HYPOTENSION
VASCULAR DISEASES
CARDIOVASCULAR DISEASES