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.
This Phase 3, 2-part, open-label, multicenter study aims to demonstrate the safety and tolerability of repeated doses of L606 in patients with PAH or PH-ILD. Cohort A: Subjects with PAH or PH-ILD receiving prior stable doses of Tyvaso and willing to switch to L606. Cohort B: Subjects with PAH (not initially on prostacyclin therapy) who are likely to receive clinical benefit from inhaled treprostinil based on the opinion of the investigator. Cohort A subjects will sequentially participate in the Main Study Period (MSP) for 2 weeks and the Open Extension Period (OEP) for 46 weeks. Cohort B subjects will sequentially participate in the MSP for 12 weeks and the OEP for 36 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
L606 inhalation suspension
Arizona Pulmonary Specialists
Scottsdale, Arizona, United States
VA Greater Los Angeles Healthcare
Los Angeles, California, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs
(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.
Time frame: 2 weeks
Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs
(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.
Time frame: 12 weeks
Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs (long-term)
(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.
Time frame: 48 weeks
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Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Summit Health Eastside Clinic
Bend, Oregon, United States
Baylor Scott and White Research Institute
Temple, Texas, United States