A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD
Recruiting
Phase 3Interventional Study
Pulmonary Hypertension Due to Lung Disease (Disorder)
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
344 (estimated)
Sponsor
Liquidia Technologies, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with high blood pressure in the lungs caused by lung disease. Participants will take either L606 or a placebo for comparison while doctors monitor their health and side effects.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 80 years old.
I have lung disease confirmed by a CT scan.
I have high blood pressure in my lungs as shown by heart tests.
I have a lung function ratio that meets the study's criteria.
I can walk at least 150 meters in six minutes.
You may not be able to join if
I have different types of pulmonary hypertension that are not included.
I have significant left-sided heart disease.
I have a history of uncontrolled atrial fibrillation.
I have severe obstructive sleep apnea.
I have had a worsening lung disease or active infection recently.
I have started pulmonary rehabilitation.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 ta…
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.
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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…
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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