76 Participants Needed

REGN7544 for Low Blood Pressure from Sepsis

Recruiting at 13 trial locations
CT
Overseen ByClinical Trials Administrator
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Regeneron Pharmaceuticals
Must be taking: Vasopressors
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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)

Who Is on the Research Team?

CT

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

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.
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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • REGN7544
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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: REGN7544Experimental Treatment1 Intervention
Group II: Placebo (PB)Placebo Group1 Intervention

Find a Clinic Near You

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 profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security