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RecruitingPhase 3

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether L606 is safe and helps adults ages 18 to 80 with high blood pressure in the lungs caused by interstitial lung disease (PH-ILD). It will check how far people can walk in six minutes and how long it takes for their disease to get worse. People will be assigned by chance to get L606 or a placebo, which has no active medicine.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18 to 80 years old.
  • Have interstitial lung disease, which affects tissue in the lungs, confirmed by a detailed chest CT scan.
  • Have high blood pressure in the lungs confirmed by a right heart catheter test, which measures pressure using a thin tube.
  • Have resistance to blood flow in the lungs of at least 4 Wood units.
  • Have an average lung artery pressure of at least 25 mmHg.
  • Have a heart filling pressure, measured as PCWP or LVEDP, of 15 mmHg or less.
  • Have a breathing test ratio called FEV1/FVC above 0.70.
  • Can walk at least 150 meters in six minutes.

Who can't join

  • Have high blood pressure in the lungs in WHO Group 1, 2, 4, or 5, rather than Group 3.
  • Have significant disease on the left side of the heart shown by a heart ultrasound.
  • Have a history of atrial fibrillation, an irregular heartbeat, that is ongoing, permanent, or not controlled.
  • Have severe obstructive sleep apnea, which causes breathing to stop and start during sleep.
  • Have had a flare-up of lung disease or an active breathing infection needing antibiotics.
  • Are starting pulmonary rehabilitation, a program to help with breathing and activity.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (13)

AZ

CA

CO

FL

IL

IN

NY

OR

SC