Trials / Recruiting
RecruitingNCT07179380
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 344 (estimated)
- Sponsor
- Insmed Incorporated · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Treprostinil Palmitil Inhalation Powder | Oral inhalation using a capsule-based dry powder inhaler device. |
| DRUG | Placebo | Oral inhalation using a capsule-based dry powder inhaler device. |
Timeline
- Start date
- 2026-01-07
- Primary completion
- 2028-12-30
- Completion
- 2028-12-30
- First posted
- 2025-09-17
- Last updated
- 2026-04-14
Locations
68 sites across 21 countries: United States, Argentina, Australia, Belgium, Czechia, Denmark, France, Georgia, Germany, Greece, Israel, Italy, Japan, New Zealand, Portugal, Romania, South Korea, Spain, Switzerland, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07179380. Inclusion in this directory is not an endorsement.