Re-Spire / L606-301
Research type
Research Study
Full 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)
IRAS ID
1012758
Contact name
Nicole Baker
Contact email
Sponsor organisation
Liquidia Technologies, Inc.
Eudract number
2024-517943-29
Research summary
The purpose of this study is to find out if the study medicine L606 is safe and if it helps people with high blood pressure in the lungs (pulmonary hypertension) caused by interstitial lung disease (PH-ILD). L606 is a new form of an existing medicine called treprostinil, which is already used in different forms (e.g., medicine given through a vein, pill and inhaled). L606 is investigational which means that it is not approved for use anywhere in the world. In this study, L606 will be given as a mist that people breathe in using a nebuliser (a small machine that turns liquid medicine into a fine mist). L606 uses tiny, fluid-filled “bubbles” called liposomes to carry the study medicine directly to the lungs. The main objective of this study is to measure whether people can walk further in six minutes while taking the highest dose of L606 that is safe and tolerated by them. The study will also look at how long it takes before PH-ILD gets worse and will check walking distance at different times while people are on different doses of the study medicine. Participants who decide to join 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 study medicine. The study is “double-blinded,” which means that neither the participants nor the study doctor knows whether someone is taking L606 or placebo. This “blinded treatment phase,” will last about 24 weeks (around 6 months). After that, participants can choose to stay in the study for longer and participate in “the open label phase” where everyone will receive L606, for up to 6 years.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
26/SC/0009
Date of REC Opinion
9 Mar 2026
REC opinion
Further Information Favourable Opinion