Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Not Applicable

Not yet recruiting

• Conditions: Pulmonary Hypertension; Interstitial Lung Disease
• Interventions: Drug: Treprostinil Palmitil Inhalation Powder; Drug: Placebo

• Registration Number: NCT07179380
• Lead Sponsor: Insmed Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-10
• Study First Submitted QC: 2025-09-10
• Last Update Submitted: 2025-09-10
• Study First Posted: 2025-09-17
• Last Update Posted: 2025-09-17
• Study Start: 2025-10-01
• Primary Completion: 2028-12-30
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 344

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treprostinil Palmitil Inhalation Powder	Treprostinil Palmitil Inhalation Powder	Participants will receive TPIP, once daily (QD), at a starting dose of 80 micrograms (μg) to maximum tolerated dose up to 1280 μg for 24 weeks.
Placebo	Placebo	Participants will receive a placebo matching TPIP QD for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Change in 6MWD Measured at Peak Exposure From Baseline to Week 24	Baseline, Week 24

Secondary Outcome Measures

Name	Time	Method
Time From Randomization to First Clinical Worsening Over the 24-Week Treatment Period	Up to Week 24
Time From Randomization to First Major Morbidity or Mortality Event Over the 24-Week Treatment Period	Up to Week 24
Change From Baseline in N-Terminal Pro Hormone Brain Natriuretic Peptide (NT-proBNP) Plasma Concentration Over 24 Weeks	Baseline up to Week 24
Number of Participants With Greater Than or Equal to (>=) 30% Decrease in NT-proBNP or Who Maintained/Achieved Less Than (<) 300 Nanogram per Liter (ng/L) of NT-proBNP Level at Week 24	At Week 24
Change in 6MWD Measured at Trough Exposure From Baseline to Week 22	Baseline, Week 22
Change From Baseline in 6MWD Measured at Peak Exposure Over 20 Weeks	Baseline up to Week 20
Mean Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Total Symptom Domain Score Over 24 Weeks	Baseline up to Week 24
Plasma Concentrations of Treprostinil Palmitil (TP) and Treprostinil (TRE)	Pre-dose and post-dose at multiple timepoints up to Week 24