Health Trials

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

ConditionPulmonary Hypertension Due to Lung Disease (Disorder)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLiquidia Technologies, Inc.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Participant is between 18 years to 80 years old.

Has a confirmed diagnosis of ILD based on High Resolution Computed Tomography (HRCT) chest imaging.

Pulmonary vascular resistance (PVR) ≥ 320 dynes.sec/cm5 (i.e. 4 Woods Units (WU)), and

Mean Pulmonary Artery Pressure (mPAP) of ≥ 25 mmHg, and

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • L606

    Drug

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

  • Placebo

    Drug

    Placebo will match L606 but contain no treprostinil.

Treatment groups

344 Participants
are divided into 2 treatment groups
Group A: L606 (in combination with nebulizer)Experimental treatment 1 intervention
Group B: Placebo (in combination with nebulizer)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)

Time frame
16 weeks

Secondary outcomes

1

Time to first occurrence of: -Death -Hospitalization due to a cardio-pulmonary indication related to underlying disease -Lung transplant -Decrease in 6MWD > 15% from Baseline related to disease under study at 2 consecutive visits >1 week apart

Time frame
24 weeks
2

Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)

Time frame
16 weeks
3

Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Liquidia Technologies, Inc.

Lead sponsor

Source ClinicalTrials.gov
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