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Looking for participantsPhase3

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

Sponsor: Liquidia Technologies, Inc.

NCT ID: NCT07285655

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
L606 (drug), Placebo (drug)
How long the study runs
Study runs about 68 months (dates as stated)
About the drug or intervention
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.
Patient visit burden
Not specified by the sponsor

In plain English

This phase 3 study is looking at how safe and effective a treatment called L606 is for people with pulmonary hypertension caused by lung disease (often shortened to PH-ILD). It is for adults aged 18 to 80 with interstitial lung disease (ILD, a type of lung scarring) confirmed by a detailed chest scan. The sponsor is Liquidia Technologies, Inc.

Who can take part

  • Adults aged 18 to 80
  • Confirmed diagnosis of ILD based on a detailed chest scan (HRCT)
  • Pulmonary hypertension shown by a right heart catheterisation test, with specific pressure and resistance measurements
  • Lung breathing test result (FEV1/FVC ratio) above 0.70
  • Able to walk at least 150 metres in 6 minutes

Who may not be able to

  • Pulmonary hypertension in certain other WHO classification groups (1, 2, 4 or 5)
  • Significant disease of the left side of the heart, based on an echocardiogram (heart ultrasound)
  • History of persistent, permanent or uncontrolled atrial fibrillation (an irregular heart rhythm)
  • Severe obstructive sleep apnoea
  • A recent flare-up of lung disease or a chest infection needing antibiotics
  • Recently started pulmonary rehabilitation

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 80 Years
Who
All
Number of participants
344
Started
2026-04-23
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for pulmonary hypertension due to lung disease (disorder)
  • • Phase3 - 344 participants
  • • 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)

Who can take part?

  • • Ages 18 Years to 80 Years
  • • Diagnosed with pulmonary hypertension due to lung disease (disorder)

Where?

  • • Bath - Royal United Hospitals Bath NHS Foundation Trust
  • • London - Royal Free London NHS Foundation Trust Hospital - Royal Free Hospital
  • • London - Royal Bromptom Hospital
  • • Plymouth - University Hospitals Plymouth NHS Trust - Derriford Hospital
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

Pulmonary Hypertension Due to Lung Disease (Disorder)

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 80 Years
  • Who can join: All genders

What the study is looking for

  • ✓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:
  • ✓lung vascular resistance (PVR) ≥ 320 dynes.sec/cm5 (i.e. 4 Woods Units (WU)), and
  • ✓Mean lung Artery Pressure (mPAP) of ≥ 25 mmHg, and

Who cannot take part

  • ✗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.
See the full 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.

Where Is This Study? (5 UK sites)

Royal United Hospitals Bath NHS Foundation Trust

Bath, United Kingdom

Recruiting
Hospital R&D contact (matched)

Amy Lloyd

ruh-tr.researchgovernance@nhs.net01225 821669

Royal Free London NHS Foundation Trust Hospital - Royal Free Hospital

London NW3 2QG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

Royal Bromptom Hospital

London SW3 6NP, United Kingdom

Recruiting

University Hospitals Plymouth NHS Trust - Derriford Hospital

Plymouth PL6 8DH, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&D Manager

plh-tr.RD-office@nhs.net01752 431776

Sheffield Teaching Hospital NHS Foundation Trust - Royal Hallamshire Hospital

Sheffield S10 2JF, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

How to Get in Touch

Liquidia Point of Contact

Sponsor contact

CONTACT

1-888-241-6906 LiquidiaStudies@liquidia.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08