TPIP Treatment for Pulmonary Hypertension with Lung Disease

An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Recruiting Phase 3 Interventional Study
Pulmonary Hypertension Interstitial Lung Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
344 (estimated)
Sponsor
Insmed Incorporated · Industry
Who this trial is looking for

This trial is looking for individuals with pulmonary hypertension linked to interstitial lung disease who have already completed an earlier study. Participants will take TPIP for a longer period to see how safe and tolerable the treatment is.

Are You a Good Fit for This Trial?
Must not be taking ProstacyclinEndothelin receptor antagonistsSoluble guanylate cyclase stimulators
Rules you out Pulmonary Hypertension WHO Groups 1, 2, 4 or 5Combined pulmonary fibrosis and emphysema

You may be able to join if

  • I have completed the lead-in TPIP study.
  • I can provide signed consent for participating.
  • I agree not to join other clinical trials or use experimental drugs while in this study.

You may not be able to join if

  • I had serious side effects from TPIP in the earlier study.
  • I need current treatment for pulmonary arterial hypertension.
  • I have been diagnosed with certain types of pulmonary hypertension.
  • I have heart failure or similar heart problems.
  • I am allergic to treprostinil or any of its ingredients.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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).

Trial Locations
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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 pa…
Contacts

Insmed Incorporated

18444467633

medicalinformation@insmed.com

CONTACT