REGN7544 for Low Blood Pressure from Sepsis

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Regeneron Pharmaceuticals

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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)

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

Adults aged 18-85 hospitalized with a serious infection (sepsis) and low blood pressure despite IV fluids, who are on 1 or 2 vasopressors to maintain blood pressure. Participants must be receiving or about to receive antibiotics for the suspected infection.

Inclusion Criteria

I am currently taking or planning to take antibiotics for an infection.

Key

I have low blood pressure from an infection that didn't improve with IV fluids but is stable with 1 or 2 blood pressure medications.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either REGN7544 or placebo while hospitalized for sepsis-induced hypotension

Hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood pressure changes and side effects

4 weeks

Treatment Details

Interventions

• REGN7544 (Monoclonal Antibodies)

Trial Overview The trial is testing REGN7544, an experimental drug, for safety, tolerability, and effectiveness in improving blood pressure in septic patients. It measures changes in blood pressure, vasopressor dose needed, side effects of the drug, its levels in the bloodstream over time, and potential antibody development against it.

Participant Groups

Group I: REGN7544 Experimental Treatment 1 Intervention

Group II: Placebo (PB) Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School