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NCT Number: NCT07285655

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

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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Key information

Conditions

Pulmonary Hypertension Due to Lung Disease (Disorder) Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ordensklinikum Linz GmbH, Linz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

L606

Drug

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

Other names: Treprostinil Liposome Inhalation Suspension

Placebo

Drug

Placebo will match L606 but contain no treprostinil.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Liquidia Point of Contact

CONTACT

[email protected]

1-888-241-6906

Sponsors and collaborators

Lead sponsor

Liquidia Technologies, Inc.

Industry

Registry information

Official study title

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)

Acronym: Re-Spire

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Dec 16, 2025
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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