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An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
RecruitingPhase 3
A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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).
What is being tested
- Treprostinil Palmitil Inhalation Powder (drug)
- Placebo (drug)
Sponsor: Insmed Incorporated · Participants: 344 · Started: Jul 20, 2026
Contact the study team
- Insmed Incorporated · Phone: 18444467633
Official record on ClinicalTrials.gov — NCT07234032
Locations in the U.S.
| Florida | USA006, Naples |
| Oregon | USA003, Bend |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.