RecruitingPhase 3NCT07285655

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

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)


Sponsor

Liquidia Technologies, Inc.

Enrollment

344 participants

Start Date

Apr 23, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria8

  • 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.
  • EV1/FVC (ratio) > 0.70.
  • -minute walk distance ≥ 150 meters

Exclusion Criteria6

  • 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.

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Interventions

DRUGL606

L606 is a liposomal version of treprostinil intended for delivery via oral inhalation using a study issued nebulizer.

DRUGPlacebo

Placebo will match L606 but contain no treprostinil.


Locations(6)

Tampa General Hospital

Tampa, Florida, United States

St. Vincent Cardiovascular Research Institute

Indianapolis, Indiana, United States

Summit Health

Bend, Oregon, United States

Universitätsklinikum Giessen und Marburg - Standort Giessen

Giessen, Germany

Pauls Stradinš Clinical University Hospital

Riga, Latvia

University Hospitals Plymouth NHS Trust - Derriford Hospital

Plymouth, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07285655