Clinical Trials in the USA / NCT04691154
Active, not recruiting
Phase 3
A Phase 3 Study to Evaluate the Safety and Tolerability of L606 in Subjects With PAH or PH-ILD
NCT04691154 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Pulmonary Arterial HypertensionPulmonary Hypertension Due to Lung Diseases
Investigational drug(s) / intervention(s)
L606 inhalation suspension
L606 inhalation suspension: L606 inhalation suspension
Study summary
This Phase 3, 2-part, open-label, multicenter study aims to demonstrate the safety and tolerability of L606 in patients with PAH or PH-ILD. The study will determine the short-term and long-term safety and tolerability of L606 in this patient population.
Eligibility
Key Inclusion Criteria:
1. Males and females ≥18 and ≤80 years of age.
2. Diagnosed with
1. PAH belonging to at least 1 of the following subgroups of Group 1 pulmonary hypertension (PH) per European Society of Cardiology/European Respiratory Society Guidelines for the diagnosis and treatment of PH at least 1 year prior to screening. or
2. PH-ILD Group 3 European Society of Cardiology/European Respiratory Society Guidelines for the diagnosis and treatment of PH. Subjects with Group 3 PH that is not related to underlying ILD are not eligible.
3. Subjects with PAH: Documentation of having PAH as confirmed by RHC meeting the following criteria:
i. Mean PAP \>20 mmHg. ii. Pulmonary arterial wedge pressure ≤15 mmHg. iii. Pulmonary vascular resistance \>3 Wood units. Subjects with PH-ILD: Confirmation of the underlying ILD must be based on HRCT imaging with demonstration of diffuse parenchymal lung disease and documented by the Investigator or radiology report. Subjects may have any form of ILD or CPFE.
4. NYHA functional class II, III, or IV at the screening visit.
5. Can complete a screening 6MWD of ≥150 meters
6. For subjects with PAH: \>65% of predicted and FEV1/FVC ratio \>65% at screening. For subjects with PH-ILD: \>40% of predicted and FEV1/FVC ratio \>70% at screening.
Key Exclusion Criteria:
1. LVEF of ≤45% on a historical echocardiogram.
2. History of sleep apnea, or left-sided heart disease (including but not limited to aortic or mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, or coronary artery disease) per investigator's discretion.
3. Experienced an acute exacerbation of disease or hospitalization for any reason within 30 days of signing the ICF or prior to baseline.
4. Musculoskeletal disorder (eg, arthritis affecting the lower limbs, recent hip or knee joint replacement) or any disease that would likely be the primary limit to ambulation or subject is connected to a machine that is not portable enough to allow for a 6MWT.
Primary outcome measure(s)
- Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs — 2 weeks
(MSP for Cohort A): Proportion of patients with PAH or PH-ILD on a stable Tyvaso dose who would develop treatment-emergent AEs/SAEs after switching to L606 dosing for up to 2 weeks during MSP. - Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs — 12 weeks
(MSP for Cohort B): Proportion of patients with PAH (not initially on prostacyclin therapy) who would develop treatment-emergent AEs/SAEs during 12 weeks of the MSP with titration on twice daily L606. - Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs (long-term) — 48 weeks
(OEP for Cohorts A and B): Proportion of subjects with PAH or PH-ILD, choosing to continue twice daily L606 dosing for up to 48 weeks, who would develop treatment emergent AEs/SAEs up to 48 hours after the last dose.
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Pulmonary Specialists | Scottsdale | Arizona | |
| VA Greater Los Angeles Healthcare | Los Angeles | California | |
| Mayo Clinic Jacksonville | Jacksonville | Florida | |
| University of South Florida | Tampa | Florida | |
| Icahn School of Medicine at Mount Sinai | New York | New York | |
| University of Cincinnati Medical Center | Cincinnati | Ohio | |
| Summit Health Eastside Clinic | Bend | Oregon | |
| Baylor Scott and White Research Institute | Temple | Texas |
More Liquidia Technologies, Inc. trials in the USA
Other trials for the same condition
An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)
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A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)
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Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04691154 on ClinicalTrials.gov ↗ ← All trials in the USA