A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD
Recruiting · NCT07285655 · Interventional (participants receive a specific treatment) · Lead sponsor: Liquidia Technologies, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
36 locations listed across 8 US states.
- 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
- Unidade Local De Saude De Almada-Seixal E.P.E. - Almada, Portugal
- Hospital Del Mar - Barcelona, Spain
- Hospital Clinic De Barcelona - Barcelona, Spain
- Royal United Hospitals Bath NHS Foundation Trust - Bath, United Kingdom
- Universitaetsklinikum Koeln AöR - Cologne, Germany
- IRCCS Ospedale Policlinico San Martino - Genoa, Italy
- Universitair Ziekenhuis Gent - Ghent, Belgium
- 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
- Assistance Publique Hopitaux De Paris - Le Kremlin-Bicêtre, France
- Ordensklinikum Linz GmbH - Linz, Austria
- Royal Free London NHS Foundation Trust Hospital - Royal Free Hospital - London, United Kingdom
- Royal Bromptom Hospital - London, United Kingdom
- Krankenhaus Neuwittelsbach - Munich, Germany
- LMU Klinikum Muenchen AöR - Munich, Germany
- University Hospitals Plymouth NHS Trust - Derriford Hospital - Plymouth, United Kingdom
- Unidade Local De Saude De Santo Antonio E.P.E. - Porto, Portugal
- Pauls Stradinš Clinical University Hospital - Riga, Latvia
- Azienda Ospedaliero-Universitaria Policlinico Umberto I - Rome, Italy
- Hospital Universitario Marques De Valdecilla - Santander, Spain
- Sheffield Teaching Hospital NHS Foundation Trust - Royal Hallamshire Hospital - Sheffield, United Kingdom
- Royal Hobart Hospital - Hobart, Tasmania, Australia