A Study of REGN7544 for the Treatment in Adult Patients With Sepsis-Induced Hypotension

Regeneron Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Sepsis-Induced Hypotension

Treatments: Drug: REGN7544; Drug: PB

Study type: Interventional

Funder types: Industry

Identifiers

NCT06608901

2024-514946-35-00 (Registry Identifier)

R7544-SIH-2435

Details and patient eligibility

About

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)

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

76 participants in 2 patient groups, including a placebo group

REGN7544

Experimental group

Treatment:

Drug: REGN7544

Placebo (PB)

Placebo Comparator group

Treatment:

Drug: PB