RecruitingPHASE3INTERVENTIONAL

A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD

This study, called a Phase 3 trial, is looking into a new medicine called L606. It's for people who have high blood pressure in their lungs (pulmonary hypertension) due to scarring in their lungs (PH-ILD, also known as WHO Group 3). The main goal is to find out if L606 is safe to use and if it helps people walk further in a set amount of time. We'll also be carefully watching to see if it slows down the worsening of PH-ILD. Some participants will receive L606, while others will get a placebo (a dummy medicine with no active ingredients). This decision is made by chance, like flipping a coin. Doctors will constantly check for any side effects to make sure L606 is safe.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Liquidia Technologies, Inc.

Enrolment target

344

Start

23 Apr 2026

Estimated completion

01 Dec 2031

Pulmonary Hypertension Due to Lung Disease (Disorder)

What is this study about?

This study is a Phase 3 clinical trial, which means it's one of the final steps before a new medicine might be approved for wider use. It's an important step for L606, a potential new treatment for a condition called pulmonary hypertension due to lung disease, often shortened to PH-ILD. In simple terms, PH-ILD means you have high blood pressure in the arteries of your lungs, and this is caused by another lung problem, like scarring.

The main aim of this study is twofold: first, to ensure L606 is safe for people to use, and second, to see if it actually helps them. One of the key ways we'll measure how well it's working is by seeing if people can walk further in a six-minute walk test. This test is a common way to measure how well someone's lungs and heart are working together. We'll also look at how long it takes for the PH-ILD to get worse while people are taking L606. Throughout the study, doctors and nurses will closely monitor everyone for any side effects.

Taking part would mean you'd be given either L606 or a placebo (a dummy medicine that looks the same but has no active drug). This is decided randomly, like drawing straws, and neither you nor your study doctor will know which one you're receiving at first. This helps us get the clearest picture of L606's effects. After this initial part, you might have the chance to continue in an 'open-label' part of the study, where everyone receives L606.

Key takeaways

This study evaluates a potential new medicine (L606) for high blood pressure in the lungs caused by lung scarring (PH-ILD).
It aims to check if L606 is safe and helps people walk further.
Participants will be randomly assigned to receive either L606 or a placebo (dummy medicine).
Close monitoring for safety and effectiveness will occur throughout the study.
After an initial period, some participants may have the option to receive L606 regardless of their initial assignment.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 80 years old. Doctors would need to have already diagnosed you with a specific type of lung scarring based on special X-ray scans of your chest. You would also need to have undergone a procedure called a 'right heart catheterisation' which would show you have a certain level of high blood pressure in your lungs due to this scarring.

There are also some reasons why you might not be able to join. For example, if your high blood pressure in the lungs is due to other causes not related to your lung scarring, or if you have certain heart problems. You also wouldn't be able to join if you have severe sleep apnoea, or if you've recently had a flare-up of your lung condition or a chest infection requiring antibiotics. Starting a new lung rehabilitation programme would also make you ineligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 80 years old?
Do you have a confirmed diagnosis of lung scarring with high blood pressure in your lungs?
Have you had a recent right heart catheterisation showing specific levels of high blood pressure in your lungs?
Do you have certain heart or lung conditions that might prevent you from joining?
Have you recently had a severe flare-up of your lung disease or a chest infection?
Are you starting a new lung rehabilitation program?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to one of two groups by chance: one group will receive the study medicine, L606, and the other will receive a placebo (a look-alike medicine with no active ingredients). You and your study doctor won't know which one you're getting in the first part of the study. You will have regular visits to the clinic where doctors will perform various checks, such as the six-minute walk test to see how far you can walk, and monitor your overall health and any side effects. You'll continue to take the assigned medicine or placebo regularly. The total duration of your participation in the initial part of the study will be determined by the study plan, but there may be an opportunity to continue in an extension part where everyone receives L606.

Potential risks and benefits

Participating in a clinical trial could offer the benefit of potentially receiving a new treatment for your PH-ILD that isn't yet widely available. You'll also receive very close medical monitoring throughout the study. However, there are potential risks, as L606 might not work for you, or you could experience side effects that are currently unknown or more severe than expected. There's also a chance you could receive the placebo and not the active medicine. Your medical team will explain all known risks to you in detail. Remember, joining a study is always your choice, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Tampa General Hospital
Verified postcode
Tampa, United States· Recruiting
St. Vincent Cardiovascular Research Institute
Verified postcode
Indianapolis, United States· Recruiting
Summit Health
Verified postcode
Bend, United States· Recruiting
Universitätsklinikum Giessen und Marburg - Standort Giessen
Verified postcode
Giessen, Germany· Recruiting
Pauls Stradinš Clinical University Hospital
Verified postcode
Riga, Latvia· Recruiting
University Hospitals Plymouth NHS Trust - Derriford Hospital
Verified postcode
Plymouth, United Kingdom· Recruiting

Common questions

What is PH-ILD?

PH-ILD stands for Pulmonary Hypertension due to Interstitial Lung Disease. It means you have high blood pressure in the arteries of your lungs because of scarring or damage in your lung tissue.

What is a 'placebo'?

A placebo is a dummy medicine that looks exactly like the real medicine but contains no active drug. It helps researchers understand if the new medicine is truly effective or if improvements are due to other factors.

What is the 'six-minute walk test'?

This is a simple test where you walk as far as you can in six minutes. It helps doctors measure your exercise ability and how well your heart and lungs are working.

Will I know if I'm getting the real medicine or the placebo?

During the first part of the study, neither you nor your study doctor will know whether you are receiving L606 or the placebo. This is a common practice in clinical trials for accuracy.

Can I leave the study if I change my mind?

Yes, absolutely. You can choose to leave the study at any time, for any reason, and it will not affect your ongoing medical care.

How to find out more

Liquidia Point of Contact

LiquidiaStudies@liquidia.com 1-888-241-6906 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.