Viewing Study NCT06422884



Ignite Creation Date: 2024-06-16 @ 11:48 AM
Last Modification Date: 2024-10-26 @ 3:30 PM
Study NCT ID: NCT06422884
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-05-21
First Post: 2024-05-15

Brief Title: A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis WHISTLE-PF Trial
Sponsor: Endeavor Biomedicines Inc
Organization: Endeavor Biomedicines Inc

Study Overview

Official Title: A Phase 2 Multi-Center Randomized Double-Blind Controlled Trial Evaluating the Safety and Efficacy of ENV-101 in Patients With Lung Fibrosis WHISTLE-PF Trial
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The goal of this clinical trial is to evaluate the impact that ENV-101 has on lung function and key measures of fibrosis in adult patients with idiopathic pulmonary fibrosis IPF and progressive pulmonary fibrosis PPF Another goal of this study is to better understand the safety and tolerability of ENV-101 in these patient populations
Detailed Description: This trial is a 6-month randomized double-blind controlled dose-ranging trial of ENV-101 in two parallel cohorts of adult patients with lung fibrosis idiopathic pulmonary fibrosis IPF and progressive pulmonary fibrosis PPF Patients are allowed to continue treatment with approved standard of care eg nintedanib pirfenidone during the trial Patients will be randomized to one of 3 dose levels of ENV-101 or placebo at baseline The objectives of this trial are to characterize the efficacy antifibrotic activity and safety of ENV-101 to select the Phase 3 dose of ENV-101 in each indication

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: None