Phase 3Recruiting
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) (PALM-ILD)
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
- Sponsor
- Insmed Incorporated (Industry)
- Enrolment
- 344 planned
- Conditions
- Pulmonary Hypertension; Interstitial Lung Disease
- Interventions
- Treprostinil Palmitil Inhalation Powder; Placebo
- Ages
- adults, older adults
- Registry
- NCT07179380, CTIS2025-521558-40-00, jRCT2031250506
Full record on ClinicalTrials.gov
From the registry
The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP versus placebo on exercise capacity in adults with PH-ILD.
Primary outcomes
- Change in 6 Minute Walk Distance (6MWD) Measured at Peak Exposure From Baseline to Week 24
History
Primary completion expected
Last registry update
Started
Registered