NCT05649722

An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term Use of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Insmed Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-211 (NCT05176951) and other lead-in studies of TPIP in participants with PH-ILD.

Conditions

• Pulmonary Hypertension
• Interstitial Lung Disease

Interventions

Type	Name	Description
DRUG	Treprostinil Palmitil Inhalation Powder	Oral inhalation using a capsule-based dry powder inhaler device.
DRUG	Placebo	Oral placebo inhalation using a capsule-based dry powder inhaler device.

Timeline

• Start date: 2023-05-11
• Primary completion: 2026-03-14
• Completion: 2026-03-14
• First posted: 2022-12-14
• Last updated: 2026-02-27

Locations

22 sites across 7 countries: Argentina, Australia, Belgium, Germany, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study