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 3Interventional Study
Pulmonary HypertensionInterstitial 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 takingProstacyclinEndothelin receptor antagonistsSoluble guanylate cyclase stimulators
Rules you outPulmonary 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.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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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Status
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…
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.
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