A Phase 3 Study to Evaluate the Safety and Efficacy of L606 (Treprostinil Liposome Inhalation Suspension) in Pulmonary Hypertension Associated with Interstitial Lung Disease

What this Trial Is About

Researchers are evaluating the safety and effects of L606 in people with high blood pressure in the lungs caused by interstitial lung disease, known as pulmonary hypertension associated with interstitial lung disease (PH-ILD, WHO Group 3). This phase 3 study aims to see if L606 helps people walk further in six minutes and to monitor how long it takes for their condition to worsen. The study is sponsored by Liquidia Technologies, Inc. and includes close monitoring for side effects to ensure safety. Participants are randomly assigned to receive either L606, delivered as a liposomal form of treprostinil via a nebulizer, or a placebo that looks like L606 but contains no active medicine. After the initial blinded phase, those who join may enter an open-label extension where everyone receives L606. This helps researchers compare the effects of L606 versus placebo over time. During the study, participants will take the six-minute walk test to measure how far they can walk. Doctors will assess changes in walking distance at 16 and 24 weeks, and track serious events like hospitalization, lung transplant, or death. The study includes regular evaluations for side effects and safety. Participation lasts through the initial treatment and may continue into the extension phase, with ongoing monitoring.

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