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).
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.
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.
Single group
Treprostinil Palmitil Inhalation Powder
DrugOral inhalation using a capsule-based dry powder.
Placebo
DrugOral inhalation in initial double-dummy titration period.
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)
Change From Baseline in 6-Minute Walk Distance (6MWD) Measured Post-Dose
Absolute Change From Baseline in Forced Vital Capacity (FVC)
Percent Change From Baseline in Forced Vital Capacity (FVC)
Absolute Change From Baseline in Percent Predicted FVC (FVC% pred)
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