RECRUITING

REGN5381 in Adult Participants With Heart Failure With Reduced Ejection Fraction

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is researching an experimental drug called REGN5381 (called "study drug"). The study is focused on patients with heart failure with reduced ejection fraction (ie, the heart is not functioning as well as it should). The aim of the study is to see how safe, tolerable, and effective the study drug is. The study is looking at several other research questions, including: * 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 study drug less effective or could lead to side effects)

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of a Single Dose of REGN5381, an NPR1 Monoclonal Antibody Agonist, in Patients With Chronic Heart Failure With Reduced Ejection Fraction

Quick Facts

Study Start:2024-04-11
Study Completion:2026-04-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06237309

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Clinical Trials Administrator
CONTACT
844-734-6643
clinicaltrials@regeneron.com

Principal Investigator

Clinical Trials Administrator
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

Flourish Research - Miami (Kendall) (Formerly Clinical Site Partners)
Miami, Florida, 33186
United States
Flourish Research - Orlando (Formerly Clinical Site Partners)
Winter Park, Florida, 32789
United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

  • Clinical Trials Administrator, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-11
Study Completion Date2026-04-15

Study Record Updates

Study Start Date2024-04-11
Study Completion Date2026-04-15

Terms related to this study

Keywords Provided by Researchers

  • Heart failure with reduced ejection fraction (HFrEF)
  • Reduced ejection fraction
  • N-terminal pro-brain natriuretic peptide (NT-proBNP) hormone

Additional Relevant MeSH Terms

  • Heart Failure