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)
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
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.
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