RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Liquidia Technologies, Inc. • ClinicalTrials.gov ID: NCT07285655

Registry updated: 2026-10-14

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Description

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.

Interventions

L606 (Drug)
L606 is a liposomal version of treprostinil intended for delivery via oral inhalation using a study issued nebulizer.
Placebo (Drug)
Placebo will match L606 but contain no treprostinil.

Eligibility criteria

Inclusion Criteria: * Participant is between 18 years to 80 years old. * Has a confirmed diagnosis of ILD based on High Resolution Computed Tomography (HRCT) chest imaging. * Evidence of PH as demonstrated from Right Heart Catheterization (RHC) with the following hemodynamic parameters: * Pulmonary vascular resistance (PVR) ≥ 320 dynes.sec/cm5 (i.e. 4 Woods Units (WU)), and * Mean Pulmonary Artery Pressure (mPAP) of ≥ 25 mmHg, and * \- Pulmonary capillary wedge pressure (PCWP) or Left-Ventricular End Diastolic Pressure (LVEDP) of ≤ 15 mmHg. * FEV1/FVC (ratio) \> 0.70. * 6-minute walk distance ≥ 150 meters Exclusion Criteria: * PH in the updated WHO Classification Groups 1, 2, 4, or 5. * Has evidence of clinically significant left-sided heart disease as defined by echocardiography. * Participants with history of persistent/permanent or uncontrolled atrial fibrillation. * Participants with severe obstructive sleep apnea. * Has experienced exacerbation of underlying lung disease or active respiratory infection requiring antibiotics. * Initiation of pulmonary rehabilitation. Note: Other protocol defined inclusion/exclusion criteria may apply.

Conditions

Pulmonary Hypertension Due to Lung Disease (Disorder)

Locations

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
Medical University of South Carolina- Nexus Research Clinic — Charleston, South Carolina, United States
Royal Hobart Hospital — Hobart, Tasmania, Australia
Ordensklinikum Linz GmbH — Linz, Austria
Hopital Erasme — Anderlecht, Belgium
Universitair Ziekenhuis Gent — Ghent, Belgium
UZ Leuven — Leuven, Belgium
Peter Lougheed Center — Calgary, Canada
Hospices Civils De Lyon — Bron, France
Assistance Publique Hopitaux De Paris — Le Kremlin-Bicêtre, France
Universitaetsklinikum Koeln AöR — Cologne, Germany
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen GmbH — Essen, 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
Fondazione IRCCS Policlinico San Matteo — Pavia, 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 Coimbra E.P.E. — Coimbra, 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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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