A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD (NCT07285655) | Clinical Trial Compass
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD
United States, Austria, Belgium344 participantsStarted 2026-04-23
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)