Long-Term TPIP Extension for PH-ILD (open-label)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label extension follows participants who completed the lead-in PH-ILD TPIP trial to assess the safety and tolerability of continuing Treprostinil Palmitil Inhalation Powder. It compares TPIP to placebo in an extension setting and monitors adverse events, dosing tolerance, and ongoing safety signals over time. Eligible participants must have finished the prior TPIP study and be willing to remain in an interventional trial without starting other investigational treatments. The study is conducted at sites in the United States (Naples, FL and Bend, OR) and in Prague, Czech Republic. Primary goals focus on long-term safety in a PH-ILD population already exposed to TPIP.

Why it matters

Who can join: the full rules

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.

Where it's running

• Usa006
  Naples, Florida, United States Recruiting
• Usa003
  Bend, Oregon, United States Recruiting
• Cze001
  Prague, Czechia Recruiting
• Fra003
  Le Kremlin-Bicêtre, France Recruiting
• Geo003
  Tbilisi, Georgia Recruiting
• Deu010
  Gauting, Germany Recruiting

Study contacts

• Study coordinator: Insmed Incorporated
• Email: medicalinformation@insmed.com
• Phone: 18444467633

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.