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NCT07234032PHASE3Recruiting

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

Insmed Incorporated

Start Date

7/20/2026

Completion Date

1/22/2031

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Treprostinil Palmitil Inhalation Powder

DRUG

Placebo

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Conditions

Pulmonary HypertensionInterstitial Lung Disease

Locations

USA006

Naples, Florida 34102

United States

USA003

Bend, Oregon 97701

United States

JPN004

Narita, Chiba 286-8520

Japan

KOR001

Seoul, 3080

South Korea

KOR006

Seoul, 6351

South Korea

ESP006

Madrid, 28041

Spain

ESP003

Madrid, 28046

Spain

ESP001

Seville, 41009

Spain

TWN003

Hsinchu, 30059

Taiwan