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Clinical Trials in the USA / NCT07234032
Recruiting Phase 3

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

NCT07234032 · tracked via the Priya Life Science USA tracker
Sponsor
Insmed Incorporated
Phase
Phase 3
Started
2026-07-20
Last updated
2026-08-13

Condition(s) studied

Pulmonary HypertensionInterstitial Lung Disease

Investigational drug(s) / intervention(s)

Treprostinil Palmitil Inhalation PowderPlacebo

Treprostinil Palmitil Inhalation Powder: Oral inhalation using a capsule-based dry powder.

Placebo: Oral inhalation in initial double-dummy titration period.

Study 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 INS1009-311 (NCT07179380).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria * Participants who have completed the lead-in PH-ILD TPIP Study INS1009-311 (NCT07179380). * Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. * Agree not to participate in any other interventional trials or use investigational drugs or devices while participating in the INS1009-312 study. Exclusion Criteria * Participants who experienced any adverse events (AEs) evaluated as causally related to TPIP by the Investigator in a lead-in study, which in the opinion of the Investigator, could pose an unreasonable risk of continued treatments for the participant. * Current use or expected need for pulmonary arterial hypertension (PAH)-approved therapy, including prostacyclin, prostacyclin analogues or other prostacyclin receptor agonists, endothelin receptor antagonists, and/or soluble guanylate cyclase stimulator, or any PH-ILD approved treprostinil therapy. Use of phosphodiesterase 5 inhibitors in line with applicable guidelines is allowed. * Diagnosis of Pulmonary Hypertension World Health Organisation (WHO) Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease (including combined pulmonary fibrosis and emphysema). * Evidence of left ventricular failure, heart failure with preserved ejection fraction (HFpEF) or postcapillary PH. * Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (eg, mannitol, leucine). Note: Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
USA006 Naples Florida Recruiting
USA003 Bend Oregon Recruiting
JPN004 Narita Chiba Not Yet Recruiting
KOR001 Seoul South Korea Not Yet Recruiting
KOR006 Seoul South Korea Not Yet Recruiting
ESP006 Madrid Spain Not Yet Recruiting
ESP003 Madrid Spain Not Yet Recruiting
ESP001 Seville Spain Not Yet Recruiting
TWN003 Hsinchu Taiwan Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07234032 on ClinicalTrials.gov ↗ ← All trials in the USA