A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: L606, Placebo.
- Who it may be relevant to
- Registry conditions: Pulmonary Hypertension Due to Lung Disease (Disorder). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Austria, Belgium, France, Germany +4
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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)
Overview
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.
Interventions
- Drug L606
L606 is a liposomal version of treprostinil intended for delivery via oral inhalation using a study issued nebulizer. - Drug Placebo
Placebo will match L606 but contain no treprostinil.
Primary outcome measures
- Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT) [Time frame: 16 weeks]
Secondary outcome measures (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 [Time frame: 24 weeks]
- Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT) [Time frame: 16 weeks]
- Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT) [Time frame: 24 weeks]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- Arizona Pulmonary Specialists, Ltd. — Scottsdale
- Tampa General Hospital — Tampa
- Northwestern University — Chicago
- St. Vincent Cardiovascular Research Institute — Indianapolis
- Summit Health — Bend
Germany · 3 centers
- Universitätsklinikum Giessen und Marburg - Standort Giessen — Giessen
- University Medical Center Hamburg-Eppendorf — Hamburg
- Medizinische Hochschule Hannover — Hanover
United Kingdom · 2 centers
- Royal United Hospitals Bath NHS Foundation Trust — Bath
- University Hospitals Plymouth NHS Trust - Derriford Hospital — Plymouth
Austria · 1 center
- Ordensklinikum Linz GmbH — Linz
Belgium · 1 center
- Universitair Ziekenhuis Gent — Ghent
France · 1 center
- Assistance Publique Hopitaux De Paris — Le Kremlin-Bicêtre
Latvia · 1 center
- Pauls Stradinš Clinical University Hospital — Riga
Portugal · 1 center
- Unidade Local De Saude De Almada-Seixal E.P.E. — Almada
Spain · 1 center
- Hospital Del Mar — Barcelona
Identifiers
NCT: NCT07285655 · L606-301