JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab

Launched by PPD DEVELOPMENT, LP · Nov 20, 2024

Keywords

ClinConnect Summary

The JUST BREATHE trial is a research study looking at a new treatment called vilobelimab for patients with Acute Respiratory Distress Syndrome (ARDS), a serious condition that makes it hard to breathe. This is a Phase 2 trial, meaning it's in the early stages of testing to see how safe and effective the treatment is. Participants in the trial will be randomly assigned to receive either vilobelimab or a placebo, which is a substance with no active medication in it, to compare the effects. The study is currently recruiting adults aged 65 and older who have moderate to severe ARDS.

If someone decides to participate, they can expect close monitoring and care as part of the trial. The goal is to find out if vilobelimab can help improve their breathing and overall health. It's important to note that participants will not have to pay for the treatment or any related medical care during the study. This trial is a part of a larger effort to develop new therapies for ARDS, and every participant will contribute to important research that could benefit many others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.
• • ARDS Severity of moderate or severe based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization
• Exclusion Criteria:
• • No additional exclusion criteria beyond the exclusion criteria specified in the Master Protocol NCT06703073.