An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Starting soon · Phase 3 · Has a placebo group
Conditions studied: Pulmonary Hypertension, Interstitial Lung Disease
In brief
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).
Key facts
- Study ID
- NCT07234032
- Run by
- Insmed Incorporated
- People needed
- 344
- Starts
- 2026-06-05
- Expected to finish
- 2031-01-22
- Last updated by the study team
- 2026-05-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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