RecruitingPhase 3NCT07285655

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

A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of L606 (Treprostinil Liposome Inhalation Suspension) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (WHO Group 3)


Sponsor

Liquidia Technologies, Inc.

Enrollment

344 participants

Start Date

Apr 23, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to find out if L606 is safe and if it helps people with high blood pressure in the lungs (pulmonary hypertension) caused by interstitial lung disease (PH-ILD, WHO Group 3). One of the main ways the study will check this is by seeing if people can walk further in six minutes (called the "six-minute walk test"). Another important (secondary) goal is to see how long it takes for PH-ILD to get worse while people are taking L606. One way the study will measure this is by looking at the distance people walk at different times in the study on different doses of L606. Throughout the study, doctors will also closely monitor for any side effects people have to make sure L606 is safe. People who decide to join this study will be randomly (like tossing a coin) placed into one of two groups: one group will get L606 and the other group will get a placebo, which will look like L606 but will not contain any active medicine. At the end of the initial blinded portion of the study, study participants may have the opportunity to enroll in an open-label extension portion of the study where all participants will receive L606.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called L606 and a drug called Placebo for people with pulmonary hypertension due to lung disease (disorder). The study is currently recruiting participants at 16 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGL606

L606 is a liposomal version of treprostinil intended for delivery via oral inhalation using a study issued nebulizer.

DRUGPlacebo

Placebo will match L606 but contain no treprostinil.


Locations(16)

Arizona Pulmonary Specialists, Ltd.

Scottsdale, Arizona, United States

Tampa General Hospital

Tampa, Florida, United States

Northwestern University

Chicago, Illinois, United States

St. Vincent Cardiovascular Research Institute

Indianapolis, Indiana, United States

Summit Health

Bend, Oregon, United States

Ordensklinikum Linz GmbH

Linz, Austria

Universitair Ziekenhuis Gent

Ghent, Belgium

Assistance Publique Hopitaux De Paris

Le Kremlin-Bicêtre, France

Universitätsklinikum Giessen und Marburg - Standort Giessen

Giessen, Germany

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Pauls Stradinš Clinical University Hospital

Riga, Latvia

Unidade Local De Saude De Almada-Seixal E.P.E.

Almada, Portugal

Hospital Del Mar

Barcelona, Spain

Royal United Hospitals Bath NHS Foundation Trust

Bath, United Kingdom

University Hospitals Plymouth NHS Trust - Derriford Hospital

Plymouth, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07285655