A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD
Re-Spire
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)
1 other identifier
interventional
344
10 countries
35
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2026
Longer than P75 for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2025
CompletedFirst Posted
Study publicly available on registry
December 16, 2025
CompletedStudy Start
First participant enrolled
April 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2031
September 2, 2026
August 1, 2026
3.2 years
December 11, 2025
August 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)
16 weeks
Secondary Outcomes (3)
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
24 weeks
Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)
16 weeks
Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)
24 weeks
Study Arms (2)
L606 (in combination with nebulizer)
EXPERIMENTALPlacebo (in combination with nebulizer)
PLACEBO COMPARATORInterventions
L606 is a liposomal version of treprostinil intended for delivery via oral inhalation using a study issued nebulizer.
Placebo will match L606 but contain no treprostinil.
Eligibility Criteria
You may qualify if:
- 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.
- minute walk distance ≥ 150 meters
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Dignity Health - St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Arizona Pulmonary Specialists, Ltd.
Scottsdale, Arizona, 85258, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095-1690, United States
University of California, San Francisco
San Francisco, California, 94143, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
National Jewish Hospital
Denver, Colorado, 80206, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Northwestern University
Chicago, Illinois, 60611, United States
St. Vincent Cardiovascular Research Institute
Indianapolis, Indiana, 46260, United States
NYU Langone Health
New York, New York, 10016, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Summit Health
Bend, Oregon, 97701, United States
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Ordensklinikum Linz GmbH
Linz, 4020, Austria
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Assistance Publique Hopitaux De Paris
Le Kremlin-Bicêtre, 94270, France
Universitaetsklinikum Koeln AöR
Cologne, 50937, Germany
Universitätsklinikum Giessen und Marburg - Standort Giessen
Giessen, 35392, Germany
Universitaetsmedizin Greifswald KöR
Greifswald, 17489, Germany
University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Krankenhaus Neuwittelsbach
Munich, 80639, Germany
LMU Klinikum Muenchen AöR
Munich, 81377, Germany
IRCCS Ospedale Policlinico San Martino
Genoa, 16132, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Rome, 00161, Italy
Pauls Stradinš Clinical University Hospital
Riga, LV-1002, Latvia
Unidade Local De Saude De Almada-Seixal E.P.E.
Almada, 2805-267, Portugal
Unidade Local De Saude De Santo Antonio E.P.E.
Porto, 4050-011, Portugal
Hospital Del Mar
Barcelona, 08003, Spain
Hospital Clinic De Barcelona
Barcelona, 08036, Spain
Hospital Universitario Marques De Valdecilla
Santander, 39008, Spain
Royal United Hospitals Bath NHS Foundation Trust
Bath, United Kingdom
Royal Free London NHS Foundation Trust Hospital - Royal Free Hospital
London, NW3 2QG, United Kingdom
Royal Bromptom Hospital
London, SW3 6NP, United Kingdom
University Hospitals Plymouth NHS Trust - Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Sheffield Teaching Hospital NHS Foundation Trust - Royal Hallamshire Hospital
Sheffield, S10 2JF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2025
First Posted
December 16, 2025
Study Start
April 23, 2026
Primary Completion (Estimated)
July 1, 2029
Study Completion (Estimated)
December 1, 2031
Last Updated
September 2, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share