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RecruitingNCT07234032Updated Nov 10, 2026

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

A Phase 3 interventional study of Treprostinil Palmitil Inhalation Powder and Placebo in Pulmonary Hypertension and Interstitial Lung Disease, sponsored by Insmed Incorporated. Recruiting at 12 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Insmed Incorporated · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Updated Nov 10, 2026First sites in 4 new countriesNo longer in Taiwan+3 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
344
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Pulmonary Hypertension
  • Interstitial Lung Disease

Keywords

  • pulmonary hypertension, interstitial lung disease
03

In context

Hypertension, Pulmonary

1,092 studies on the registry are indexed under Hypertension, Pulmonary; 244 are open to participants now.

This study's planned enrollment of 344 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Insmed Incorporated is the lead sponsor of 50 studies on the registry; 8 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 8 (29%) have results posted.

Browse Insmed Incorporated studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants who have completed the lead-in PH-ILD TPIP Study INS1009-311 (NCT07179380).
  • Capable of giving signed 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 drugs or devices while participating in the INS1009-312 study.

Exclusion criteria

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 (HFpEF) or postcapillary PH.
  • Known or to treprostinil or TPIP or TPIP formulation (eg, mannitol, leucine).

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
344 participants (estimated)

Study arms

  • Experimental
    Treprostinil Palmitil Inhalation Powder (TPIP)

    Participants transitioning from study INS1009-311 (NCT07179380) will undergo an initial double-dummy titration with the stable dose from the lead-in study and either TPIP or placebo for 4 weeks. They will then receive open-label TPIP at a stable maintenance dose with optional escalation (80-1280 micrograms once daily) for the remainder of the 104-week treatment period.

    Drug: Treprostinil Palmitil Inhalation Powder · Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to 108 weeks

Secondary outcomes

  1. Change From Baseline in 6-Minute Walk Distance (6MWD) Measured Post-Dose

    Time frame: Up to 104 weeks

  2. Absolute Change From Baseline in Forced Vital Capacity (FVC)

    Time frame: Up to 104 weeks

  3. Percent Change From Baseline in Forced Vital Capacity (FVC)

    Time frame: Up to 104 weeks

  4. Absolute Change From Baseline in Percent Predicted FVC (FVC% pred)

    Time frame: Up to 104 weeks

  5. Percent Change From Baseline in Percent Predicted FVC (FVC% pred)

    Time frame: Up to 104 weeks

  6. Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: Up to 104 weeks

  7. Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: Up to 104 weeks

  8. Absolute Change From Baseline in Percent Predicted FEV1 (FEV1%)

    Time frame: Up to 104 weeks

  9. Percent Change From Baseline in Percent Predicted FEV1 (FEV1%)

    Time frame: Up to 104 weeks

  10. Change From Baseline in the Plasma Concentration of N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP)

    Time frame: Up to 104 weeks

  11. Annualized Rate of Occurrence of Exacerbations of Interstitial Lung Disease (ILD)

    Time frame: Up to 104 weeks

  12. Percentage of Participants With a Clinical Worsening Events

    Time frame: Up to 104 weeks

  13. Mean Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Domain Score

    Time frame: Up to 104 weeks

  14. Mean Change From Baseline in L-PF Cough Domain Score

    Time frame: Up to 104 weeks

  15. Mean Change From Baseline in L-PF Dyspnea Domain Score

    Time frame: Up to 104 weeks

  16. Mean Change From Baseline in L-PF Impact Domain Score

    Time frame: Up to 104 weeks

  17. Mean Change From Baseline in the EuroQoL- 5 Dimensions (EQ-5D-5L) Index Score

    Time frame: Up to 104 weeks

  18. Mean Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS)

    Time frame: Up to 104 weeks

  19. Percentage of Participants With Major Morbidity or Mortality Events

    Time frame: Up to 104 weeks

07

Study locations

12 of 12 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Sites
7 sites added, 4 sites removed — first sites in Czechia, France, Georgia and Germany; no longer in Taiwan. 3 sites changed recruiting status (3 now recruiting)
Show 3 sites
  • JPN004 · Narita, JapanNot yet recruiting→Recruiting
  • KOR001 · Seoul, South KoreaNot yet recruiting→Recruiting
  • ESP006 · Madrid, SpainNot yet recruiting→Recruiting
Show 7 added (2 Germany, 1 Czechia, 1 France, 1 Georgia, 1 Japan, 1 Spain)
  • CZE001 · Prague, Czechia
  • FRA003 · Le Kremlin-Bicêtre, France
  • GEO003 · Tbilisi, Georgia
  • DEU010 · Gauting, Germany
  • DEU006 · München, Germany
  • JPN007 · Yokohama, Japan
  • ESP003 · Madrid, Spain
Show 4 removed
  • KOR006 · Seoul, South Korea
  • ESP003 · Madrid, Spain
  • ESP001 · Seville, Spain
  • TWN003 · Hsinchu, Taiwan
across 2 updates, Oct 27, 2026 – Nov 10, 2026
Show all 2 updates
  1. Nov 10, 2026
    1 site added
    Show site
    • ESP003 · Madrid, Spain
    + 1 other change: verification date
  2. Oct 27, 2026
    6 sites added, 4 sites removed — first sites in Czechia, France, Georgia and Germany; no longer in Taiwan. 3 sites changed recruiting status (3 now recruiting)
    Show 3 sites
    • JPN004 · Narita, JapanNot yet recruiting→Recruiting
    • KOR001 · Seoul, South KoreaNot yet recruiting→Recruiting
    • ESP006 · Madrid, SpainNot yet recruiting→Recruiting
    Show 6 added (2 Germany, 1 Czechia, 1 France, 1 Georgia, 1 Japan)
    • CZE001 · Prague, Czechia
    • FRA003 · Le Kremlin-Bicêtre, France
    • GEO003 · Tbilisi, Georgia
    • DEU010 · Gauting, Germany
    • DEU006 · München, Germany
    • JPN007 · Yokohama, Japan
    Show 4 removed
    • KOR006 · Seoul, South Korea
    • ESP003 · Madrid, Spain
    • ESP001 · Seville, Spain
    • TWN003 · Hsinchu, Taiwan
    + 2 other changes: identifiers and verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07234032
Lead sponsor
Insmed Incorporated
Responsible party
Sponsor
First posted
Nov 18, 2025
Start date
Jul 20, 2026
Primary completion
Jan 22, 2031 (estimated)
Completion
Jan 22, 2031 (estimated)
Last update
Nov 10, 2026

Study contacts

Insmed Incorporated
Contact
medicalinformation@insmed.com
18444467633
Study Director
study director · Insmed Incorporated

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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