A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease

Insmed Incorporated

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

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed 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 o…

Interventions

Drug
Treprostinil Palmitil Inhalation Powder
Oral inhalation using a capsule-based dry powder.
Drug
Placebo
Oral inhalation in initial double-dummy titration period.

Summary

Eligibility

Interventions

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