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Tests treatment safety and results for Pulmonary Hypertension Due to Lung Disease (Disorder)
Official title A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD
ClinicalTrials.gov ID: NCT07285655
What this study is testing
What is L606?
L606 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for pulmonary hypertension due to lung disease (disorder).
Also referred to as Treprostinil Liposome Inhalation Suspension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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").
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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
You likely can't join 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. Note: Other protocol defined inclusion/exclusion criteria may apply.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Bend, Oregon, United States
- Linz, Austria
- Ghent, Belgium
- Le Kremlin-Bicêtre, France
- Giessen, Germany
- Hamburg, Germany
- Hanover, Germany
- Riga, Latvia
- Almada, Portugal
- Barcelona, Spain
- Bath, United Kingdom
- Plymouth, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Tampa, Florida, United States; Chicago, Illinois, United States; Indianapolis, Indiana, United States; Bend, Oregon, United States; Linz, Austria and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.