A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD
Start Date
4/23/2026
Completion Date
12/1/2031
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 Criteria
Age Range: 18 years to 80 years
Interventions
L606
Placebo
Conditions
Locations
Arizona Pulmonary Specialists, Ltd.
Scottsdale, Arizona 85258
United States
Tampa General Hospital
Tampa, Florida 33606
United States
Northwestern University
Chicago, Illinois 60611
United States
St. Vincent Cardiovascular Research Institute
Indianapolis, Indiana 46260
United States
Summit Health
Bend, Oregon 97701
United States
Ordensklinikum Linz GmbH
Linz, 4020
Austria
Universitair Ziekenhuis Gent
Ghent, 9000
Belgium
Assistance Publique Hopitaux De Paris
Le Kremlin-Bicêtre, 94270
France
Universitätsklinikum Giessen und Marburg - Standort Giessen
Giessen, 35392
Germany
University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Germany
Medizinische Hochschule Hannover
Hanover, 30625
Germany
Pauls Stradinš Clinical University Hospital
Riga, LV-1002
Latvia
Unidade Local De Saude De Almada-Seixal E.P.E.
Almada, 2805-267
Portugal
Hospital Del Mar
Barcelona, 08003
Spain
Royal United Hospitals Bath NHS Foundation Trust
Bath,
United Kingdom
University Hospitals Plymouth NHS Trust - Derriford Hospital
Plymouth, PL6 8DH
United Kingdom