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A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD
Sponsor: Liquidia Technologies, Inc.
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
344
Start Date
2026-04-23
Completion Date
2031-12
Last Updated
2026-09-02
Healthy Volunteers
No
Interventions
L606
L606 is a liposomal version of treprostinil intended for delivery via oral inhalation using a study issued nebulizer.
Placebo
Placebo will match L606 but contain no treprostinil.
Locations (36)
Dignity Health - St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Arizona Pulmonary Specialists, Ltd.
Scottsdale, Arizona, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
National Jewish Hospital
Denver, Colorado, United States
Tampa General Hospital
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
St. Vincent Cardiovascular Research Institute
Indianapolis, Indiana, United States
NYU Langone Health
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Summit Health
Bend, Oregon, United States
Royal Hobart Hospital
Hobart, Tasmania, Australia
Ordensklinikum Linz GmbH
Linz, Austria
Universitair Ziekenhuis Gent
Ghent, Belgium
Assistance Publique Hopitaux De Paris
Le Kremlin-Bicêtre, France
Universitaetsklinikum Koeln AöR
Cologne, Germany
Universitätsklinikum Giessen und Marburg - Standort Giessen
Giessen, Germany
Universitaetsmedizin Greifswald KöR
Greifswald, Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Krankenhaus Neuwittelsbach
Munich, Germany
LMU Klinikum Muenchen AöR
Munich, Germany
IRCCS Ospedale Policlinico San Martino
Genoa, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Rome, Italy
Pauls Stradinš Clinical University Hospital
Riga, Latvia
Unidade Local De Saude De Almada-Seixal E.P.E.
Almada, Portugal
Unidade Local De Saude De Santo Antonio E.P.E.
Porto, Portugal
Hospital Del Mar
Barcelona, Spain
Hospital Clinic De Barcelona
Barcelona, Spain
Hospital Universitario Marques De Valdecilla
Santander, Spain
Royal United Hospitals Bath NHS Foundation Trust
Bath, United Kingdom
Royal Free London NHS Foundation Trust Hospital - Royal Free Hospital
London, United Kingdom
Royal Bromptom Hospital
London, United Kingdom
University Hospitals Plymouth NHS Trust - Derriford Hospital
Plymouth, United Kingdom
Sheffield Teaching Hospital NHS Foundation Trust - Royal Hallamshire Hospital
Sheffield, United Kingdom