Treatment of low blood pressure in adults with sepsis using REGN7544

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

This study is testing a new drug called REGN7544 to see if it can help adults with low blood pressure from sepsis feel better while they are in the hospital.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Regeneron Pharmaceuticals (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 5 sites (Atlanta, Georgia and 4 other locations)
• Trial ID: NCT06608901 on ClinicalTrials.gov

What this trial studies

This study investigates the experimental drug REGN7544 in adult patients hospitalized with sepsis-induced hypotension who are receiving standard vasopressor treatment. The primary focus is to evaluate the safety, tolerability, and effectiveness of REGN7544 by monitoring its impact on blood pressure and the total vasopressor dosage during hospitalization. Additional research questions include assessing side effects, drug concentration in the blood, and the body's immune response to the drug. Participants will be closely monitored to gather comprehensive data on the drug's performance in this critical condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with proven or suspected infections leading to sepsis-induced hypotension that has not responded to IV fluids.

Not a fit: Patients whose hypotension is due to non-sepsis causes or those with severe cardiac conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve blood pressure management in patients with sepsis-induced hypotension, potentially reducing complications and improving outcomes.

How similar studies have performed: Other studies have explored treatments for sepsis-induced hypotension, but the specific approach with REGN7544 is novel and has not been extensively tested.

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

Where this trial is running

Atlanta, Georgia and 4 other locations

• Emory University Hospital — Atlanta, Georgia, United States (Recruiting)
• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
• Harvard Medical School - Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
• CHU Dupuytren — Limoges, Nouvelle Aquitaine, France (Recruiting)
• Hopital Cochin — Paris, Île-de-France, France (Recruiting)

Study contacts

• Study coordinator: Clinical Trials Administrator

Conditions Sepsis-Induced Hypotension; Natriuretic Peptide Receptor 1; Low Blood Pressure