Clinical trial NCT06608901: A Study of REGN7544 for the Treatment in Adult Patients With Sepsis-Induced Hypotension
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Sepsis-Induced Hypotension
Keywords: Natriuretic Peptide Receptor 1 (NPR1)
Low Blood Pressure
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-09-23
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 your 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)


Eligibility criteria: Key Inclusion Criteria:

1. Proven or suspected infection defined as administration or planned administration of antibiotics 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. Receiving continuous neuromuscular blockade during the screening period
4. Primary cause of hypotension suspected to be due to non-sepsis cause (eg, hemorrhage, burns, or cardiogenic shock), including shock after cardiac arrest
5. Ejection fraction \<20% in the most recent known echocardiogram
6. Acute coronary syndrome based on clinical symptoms and/or electrocardiogram (ECG) during hospitalization
7. 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
8. Any prior diagnosis of severe pulmonary hypertension, as defined in the protocol
9. 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
10. Chronic mechanical ventilation for any reason or severe Chronic Obstructive Pulmonary Disease (COPD) requiring either continuous daily oxygen use or mechanical ventilation (for acute exacerbation of COPD) prior to hospital admission
11. 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

Primary outcomes:
measure: Cumulative vasopressor dose
timeFrame: Through 72 Hours
Secondary outcomes:
measure: Occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 and higher treatment-emergent adverse events (TEAEs)
timeFrame: Through 90 Days
measure: Time-weighted average mean arterial pressure (MAP)
timeFrame: Baseline Over 4 Hours
measure: Change in MAP
timeFrame: Baseline, At 4 Hours
measure: Proportion of surviving participants free of vasopressor(s)
timeFrame: At 24, 48 and 72 Hours
measure: Cumulative net fluid balance
timeFrame: Through 72 Hours
measure: Cumulative urine output
timeFrame: Through 72 Hours
measure: Cumulative fluid intake
timeFrame: Through 72 Hours
measure: Concentrations of REGN7544 in serum
timeFrame: Through 90 Days
measure: Incidence of anti-drug antibodies (ADA) to REGN7544
timeFrame: Through 90 Days
measure: Titer of ADA to REGN7544
timeFrame: Through 90 Days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Harvard Medical School - Beth Israel Deaconess Medical Center
state: Massachusetts
city: Limoges
country: France
facility: CHU Dupuytren
state: Nouvelle Aquitaine
city: Paris
country: France
facility: Hopital Cochin
state: Île-de-France
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: