Find Acute Interstitial Pneumonia Clinical Trials Near You
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)
Status: Recruiting
Location: See all (36) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Dignity Health - St. Joseph's Hospital and Medical Center
RECRUITING
Phoenix
Arizona Pulmonary Specialists, Ltd.
RECRUITING
Scottsdale
California
David Geffen School of Medicine at UCLA
RECRUITING
Los Angeles
University of California, San Francisco
RECRUITING
San Francisco
Colorado
University of Colorado Hospital
RECRUITING
Aurora
National Jewish Hospital
RECRUITING
Denver
Florida
Tampa General Hospital
RECRUITING
Tampa
Illinois
Northwestern University
RECRUITING
Chicago
Indiana
St. Vincent Cardiovascular Research Institute
RECRUITING
Indianapolis
New York
NYU Langone Health
RECRUITING
New York
University of Rochester Medical Center
RECRUITING
Rochester
Oregon
Summit Health
RECRUITING
Bend
Other Locations
Australia
Royal Hobart Hospital
RECRUITING
Hobart
Austria
Ordensklinikum Linz GmbH
RECRUITING
Linz
Belgium
Universitair Ziekenhuis Gent
RECRUITING
Ghent
France
Assistance Publique Hopitaux De Paris
RECRUITING
Le Kremlin-bicêtre
Germany
Universitaetsklinikum Koeln AöR
RECRUITING
Cologne
Universitätsklinikum Giessen und Marburg - Standort Giessen
RECRUITING
Giessen
Universitaetsmedizin Greifswald KöR
RECRUITING
Greifswald
University Medical Center Hamburg-Eppendorf
RECRUITING
Hamburg
Medizinische Hochschule Hannover
RECRUITING
Hanover
Krankenhaus Neuwittelsbach
RECRUITING
Munich
LMU Klinikum Muenchen AöR
RECRUITING
Munich
Italy
IRCCS Ospedale Policlinico San Martino
RECRUITING
Genoa
Azienda Ospedaliero-Universitaria Policlinico Umberto I
RECRUITING
Rome
Latvia
Pauls Stradinš Clinical University Hospital
RECRUITING
Riga
Portugal
Unidade Local De Saude De Almada-Seixal E.P.E.
RECRUITING
Almada
Unidade Local De Saude De Santo Antonio E.P.E.
RECRUITING
Porto
Spain
Hospital Clinic De Barcelona
RECRUITING
Barcelona
Hospital Del Mar
RECRUITING
Barcelona
Hospital Universitario Marques De Valdecilla
RECRUITING
Santander
United Kingdom
Royal United Hospitals Bath NHS Foundation Trust
RECRUITING
Bath
Royal Bromptom Hospital
RECRUITING
London
Royal Free London NHS Foundation Trust Hospital - Royal Free Hospital
RECRUITING
London
University Hospitals Plymouth NHS Trust - Derriford Hospital
RECRUITING
Plymouth
Sheffield Teaching Hospital NHS Foundation Trust - Royal Hallamshire Hospital
RECRUITING
Sheffield
Contact Information
Primary
Liquidia Point of Contact
LiquidiaStudies@liquidia.com
1-888-241-6906
Time Frame
Start Date:2026-04-23
Estimated Completion Date:2031-12
Participants
Target number of participants:344
Treatments
Experimental: L606 (in combination with nebulizer)
Placebo_comparator: Placebo (in combination with nebulizer)