Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2025-12-17 @ 4:26 AM
Study NCT ID:
NCT04691154
Status:
None
Last Update Posted:
2024-10-09 00:00:00
First Post:
2020-12-21 00:00:00
Brief Title:
A Phase 3 Study to Evaluate the Safety and Tolerability of L606 in Subjects With PAH or PH-ILD
Sponsor:
Liquidia Technologies Inc
Organization:
Liquidia Technologies, Inc.
Study Overview
Official Title:
A Phase 3, 2-Part, Open-Label Study to Evaluate the Safety and Tolerability of Liposomal Treprostinil Inhalation Suspension (L606) in Subjects With Pulmonary Arterial Hypertension or Pulmonary Hypertension Associated With Interstitial Lung Disease
Status:
None
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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. The current Phase 3 study will help determine the short-term and long-term safety and tolerability of L606 in this patient population. The study will also evaluate the steady-state pharmacokinetics (PK) of L606 as compared to Tyvaso, effects on exercise ability (6-minute walk distance \[6MWD\] and Borg Dyspnea Score), quality of life (QoL), and treatment satisfaction with L606.
Subjects who meet all the inclusion criteria and none of the exclusion criteria will be enrolled to one of the 2 cohorts:
Cohort A: Subjects with PAH or PH-ILD receiving prior stable doses of Tyvaso (4 times daily) and willing to switch to L606 (twice daily).
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 MSP for 2 weeks and the OEP for 46 weeks. A subset of up to 15 subjects from Cohort A will also participate in a PK substudy. Cohort B subjects will sequentially participate in the MSP for 12 weeks and the OEP for 36 weeks.
Subjects who meet all the inclusion criteria and none of the exclusion criteria will be enrolled to one of the 2 cohorts:
Cohort A: Subjects with PAH or PH-ILD receiving prior stable doses of Tyvaso (4 times daily) and willing to switch to L606 (twice daily).
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 MSP for 2 weeks and the OEP for 46 weeks. A subset of up to 15 subjects from Cohort A will also participate in a PK substudy. Cohort B subjects will sequentially participate in the MSP for 12 weeks and the OEP for 36 weeks.
Detailed Description:
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 The current Phase 3 study will help determine the short-term and long-term safety and tolerability of L606 in this patient population The study will also evaluate the steady-state pharmacokinetics PK of L606 as compared to Tyvaso effects on exercise ability 6-minute walk distance 6MWD and Borg Dyspnea Score quality of life QoL and treatment satisfaction with L606
Subjects who meet all the inclusion criteria and none of the exclusion criteria will be enrolled to one of the 2 cohorts
Cohort A Subjects with PAH or PH-ILD receiving prior stable doses of Tyvaso 4 times daily and willing to switch to L606 twice daily
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 MSP for 2 weeks and the OEP for 46 weeks A subset of up to 15 subjects from Cohort A will also participate in a PK substudy Cohort B subjects will sequentially participate in the MSP for 12 weeks and the OEP for 36 weeks
Subjects who meet all the inclusion criteria and none of the exclusion criteria will be enrolled to one of the 2 cohorts
Cohort A Subjects with PAH or PH-ILD receiving prior stable doses of Tyvaso 4 times daily and willing to switch to L606 twice daily
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 MSP for 2 weeks and the OEP for 46 weeks A subset of up to 15 subjects from Cohort A will also participate in a PK substudy Cohort B subjects will sequentially participate in the MSP for 12 weeks and the OEP for 36 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None