Active not recruitingPHASE2INTERVENTIONAL

A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial)

This study, called WHISTLE-PF, is looking at a new medicine called ENV-101 for adults who have lung scarring conditions like Idiopathic Pulmonary Fibrosis (IPF) or Progressive Fibrosing Interstitial Lung Disease. The main goal is to find out if ENV-101 can improve how well your lungs work and help with the scarring, as well as to check if it's safe to use. You would take ENV-101 or a dummy drug (placebo) for 6 months. Some participants will continue taking their usual lung medications. The study will help researchers decide the best dose of ENV-101 to test in future larger studies.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Endeavor Biomedicines, Inc.

Enrolment target

213

Start

15 Nov 2024

Estimated completion

01 Oct 2026

Idiopathic Pulmonary Fibrosis Progressive Fibrosing Interstitial Lung Disease

What is this study about?

This study, known as the WHISTLE-PF trial, is testing a new medicine called ENV-101. It's for adults who have lung scarring conditions, specifically Idiopathic Pulmonary Fibrosis (IPF) or Progressive Fibrosing Interstitial Lung Disease. These conditions cause scar tissue to build up in the lungs, making it harder to breathe. The researchers want to see if ENV-101 can help slow down or reduce this scarring and improve how well your lungs work.

The main aims are to understand two things: first, if ENV-101 is effective at improving lung function and reducing the scarring, and second, if it's safe and well-tolerated by patients. This type of study, called a Phase 2 trial, helps researchers choose the most promising dose of a new medicine for future, larger studies.

During the study, some participants will receive ENV-101, and others will receive a placebo – which looks like the medicine but contains no active drug. This helps scientists fairly compare the effects of ENV-101. Importantly, if you're already on approved treatments for your lung condition, you might be able to continue taking them while participating in this trial.

Key takeaways

This study is testing a new medicine, ENV-101, for lung scarring conditions.
It aims to see if ENV-101 can improve breathing and is safe.
Participants will take ENV-101 or a placebo for 6 months.
Many can continue their usual lung treatments during the study.
The study helps decide the best dose for future research.

Who may be eligible?

To join this study, you need to be at least 40 years old and have a confirmed diagnosis of Idiopathic Pulmonary Fibrosis (IPF). Your lung function, measured by tests like FVC and DLCO (which show how much air your lungs can hold and how well they use oxygen), needs to be at a certain level.

You should also be able to do breathing tests called spirometry. If you're already taking standard treatments for your lung condition, you either need to have been on a steady dose for at least 3 months, or not have taken any for at least 8 weeks before the study starts.

There are also some reasons why you might not be able to join. For example, if you have other causes for your lung disease, certain serious health conditions, or if you've smoked or vaped recently. The doctors will check all these details carefully to make sure the study is right for you.

Quick self-check

Are you 40 years old or older?
Do you have a diagnosis of Idiopathic Pulmonary Fibrosis (IPF)?
Can you do breathing tests effectively?
Have you been on stable lung treatment for at least 3 months, or not on any for 8 weeks?
Have you stopped smoking or vaping for at least 6 months?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the study, you'll be involved for about 6 months. You will be randomly assigned to receive either ENV-101 or a placebo (a dummy drug). Neither you nor your study doctor will know which one you are receiving. The study involves regular visits to the clinic where you will have various health checks, such as physical exams, blood tests, and lung function tests like spirometry. You'll also be asked about any symptoms you're experiencing. You might continue taking your current lung medications during this time. The total number of visits and the exact schedule will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial can have potential benefits, such as access to a new medicine that isn't widely available yet, which might help your condition. You'll also receive close medical attention and monitoring. However, there are also risks. The new medicine might have side effects that aren't fully known, or it might not work for you. There's also a chance you could receive the placebo and not the active drug. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (78)

Research Site
Quilmes, Argentina
Research Site
Buenos Aires, Argentina
Research Site
Buenos Aires, Argentina
Research Site
Mendoza, Argentina
Research Site
Mendoza, Argentina
Research Site
Camperdown, Australia
Research Site
Macquarie Park, Australia
Research Site
Brisbane, Australia
Research Site
South Brisbane, Australia
Research Site
Box Hill, Australia
Research Site
Nedlands, Australia
Research Site
Graz, Austria

+66 more sites — see the official record for the full list.

Common questions

What is Idiopathic Pulmonary Fibrosis (IPF)?

IPF is a disease where scar tissue builds up in your lungs, making them stiff and making it harder to breathe over time.

What is ENV-101?

ENV-101 is a new medicine being tested to see if it can help reduce lung scarring and improve breathing for people with lung conditions like IPF.

What does 'randomised, double-blind, controlled' mean?

It means participants are randomly chosen to get the real medicine or a dummy pill (placebo), and neither you nor your doctor will know which you're getting, to make the results fair.

Can I continue my current lung medications?

Yes, in many cases, you may be allowed to continue taking your approved standard treatments for your lung condition during this study.

What is a 'Phase 2' trial?

A Phase 2 trial is an early stage of testing a new medicine involving a smaller group of people to see if it works and is safe, and to figure out the best dose for future studies.