RecruitingRecruiting
A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD
NCT07285655 · Liquidia Technologies, Inc.
In plain English
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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)
About this study
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
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.
Study design
Enrollment target: 344 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-04-23
Estimated completion: 2031-12
Last updated: 2026-06-29
Interventions
Drug: L606Drug: Placebo
Primary outcomes
- • Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT) (16 weeks)
Sponsor
Liquidia Technologies, Inc. · industry
Contacts & investigators
ContactLiquidia Point of Contact · contact · LiquidiaStudies@liquidia.com · 1-888-241-6906
All locations (16)
Arizona Pulmonary Specialists, Ltd.Recruiting
Scottsdale, Arizona, United States
Tampa General HospitalRecruiting
Tampa, Florida, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
St. Vincent Cardiovascular Research InstituteRecruiting
Indianapolis, Indiana, United States
Summit HealthRecruiting
Bend, Oregon, United States
Ordensklinikum Linz GmbHRecruiting
Linz, Austria
Universitair Ziekenhuis GentRecruiting
Ghent, Belgium
Assistance Publique Hopitaux De ParisRecruiting
Le Kremlin-Bicêtre, France
Universitätsklinikum Giessen und Marburg - Standort GiessenRecruiting
Giessen, Germany
University Medical Center Hamburg-EppendorfRecruiting
Hamburg, Germany
Medizinische Hochschule HannoverRecruiting
Hanover, Germany
Pauls Stradinš Clinical University HospitalRecruiting
Riga, Latvia
Unidade Local De Saude De Almada-Seixal E.P.E.Recruiting
Almada, Portugal
Hospital Del MarRecruiting
Barcelona, Spain
Royal United Hospitals Bath NHS Foundation TrustRecruiting
Bath, United Kingdom
University Hospitals Plymouth NHS Trust - Derriford HospitalRecruiting
Plymouth, United Kingdom