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

RecruitingPhase 3Ages 18 Years - 80 YearsAllLiquidia Technologies, Inc.
NCT07285655 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 l

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📋 Eligibility rules (as published)
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.
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What it tests

  • L606
  • Placebo
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Where

44 sites
Dignity Health - St. Joseph's Hospital and Medical Center
Phoenix, United States
Arizona Pulmonary Specialists, Ltd.
Scottsdale, United States
David Geffen School of Medicine at UCLA
Los Angeles, United States
University of California, San Francisco
San Francisco, United States
University of Colorado Hospital
Aurora, United States
National Jewish Hospital
Denver, United States
Tampa General Hospital
Tampa, United States
Northwestern University
Chicago, United States

…and 36 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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