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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
Sponsor
Liquidia Technologies, Inc.
Phase
Phase 3
Started
2021-08-01
Last updated
2026-04-01

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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)

Trial sites (8)

FacilityCityRegionStatus
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
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