Pulmonary HypertensionPhase 3NCT07234032
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 study testing Treprostinil Palmitil Inhalation Powder in people with Pulmonary Hypertension and Interstitial Lung Disease, run by Insmed Incorporated at 11 sites in 8 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Interstitial Lung Disease
- What is being tested?
- Treprostinil Palmitil Inhalation Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 344 participants
- Where
- 11 sitesin 8 countries
- Study dates
- 20 Jul 2026to 22 Jan 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 8 countries
United States2 sites, 2 recruiting
- Recruiting
USA003
Bend, Oregon, 97701
- Recruiting
USA006
Naples, Florida, 34102
Japan2 sites, 2 recruiting
- Recruiting
JPN004
Narita, Chiba, 286-8520
- Recruiting
JPN007
Yokohama
About this study
Official title: A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease
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).
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease
- Being tested
- Treprostinil Palmitil Inhalation Powder, Placebo
- Keywords
- pulmonary hypertension, interstitial lung disease
- Medical subject headings
- Hypertension, Pulmonary, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treprostinil Palmitil Inhalation PowderDrug
Also called INS1009
Oral inhalation using a capsule-based dry powder.
PlaceboDrug
Oral inhalation in initial double-dummy titration period.
| Study group | Role | What they receive |
|---|---|---|
| Treprostinil Palmitil Inhalation Powder (TPIP) | Experimental | 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. Receives: Drug: Treprostinil Palmitil Inhalation Powder; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to 108 weeks
Secondary outcomes (19)
Change From Baseline in 6-Minute Walk Distance (6MWD) Measured Post-Dose
Measured: Up to 104 weeks
Absolute Change From Baseline in Forced Vital Capacity (FVC)
Measured: Up to 104 weeks
Percent Change From Baseline in Forced Vital Capacity (FVC)
Measured: Up to 104 weeks
Absolute Change From Baseline in Percent Predicted FVC (FVC% pred)
Measured: Up to 104 weeks
Percent Change From Baseline in Percent Predicted FVC (FVC% pred)
Measured: Up to 104 weeks
Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Measured: Up to 104 weeks
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Measured: Up to 104 weeks
Absolute Change From Baseline in Percent Predicted FEV1 (FEV1%)
Measured: Up to 104 weeks
Percent Change From Baseline in Percent Predicted FEV1 (FEV1%)
Measured: Up to 104 weeks
Change From Baseline in the Plasma Concentration of N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP)
Measured: Up to 104 weeks
Annualized Rate of Occurrence of Exacerbations of Interstitial Lung Disease (ILD)
Measured: Up to 104 weeks
Percentage of Participants With a Clinical Worsening Events
Measured: Up to 104 weeks
Mean Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Domain Score
Measured: Up to 104 weeks
Mean Change From Baseline in L-PF Cough Domain Score
Measured: Up to 104 weeks
Mean Change From Baseline in L-PF Dyspnea Domain Score
Measured: Up to 104 weeks
Mean Change From Baseline in L-PF Impact Domain Score
Measured: Up to 104 weeks
Mean Change From Baseline in the EuroQoL- 5 Dimensions (EQ-5D-5L) Index Score
Measured: Up to 104 weeks
Mean Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS)
Measured: Up to 104 weeks
Percentage of Participants With Major Morbidity or Mortality Events
Measured: Up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start20 Jul 2026
- Primary completion22 Jan 2031 (estimated)
- Study completion22 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insmed Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Insmed Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234032
- Sponsor's protocol ID
- INS1009-312
- Other IDs
- 2025-521769-29-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 14 Nov 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT07234032
- Acronym / sponsor ID
- INS1009-312
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease
- Keywords
- pulmonary hypertension, interstitial lung disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 22 Jan 2031 (estimated)
- Study completion
- 22 Jan 2031 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treprostinil Palmitil Inhalation Powder (TPIP) | Experimental | Drug: Treprostinil Palmitil Inhalation Powder, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treprostinil Palmitil Inhalation PowderAlso: INS1009Oral inhalation using a capsule-based dry powder. | Drug | Treprostinil Palmitil Inhalation Powder (TPIP) |
| PlaceboOral inhalation in initial double-dummy titration period. | Drug | Treprostinil Palmitil Inhalation Powder (TPIP) |
Primary outcome
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 108 weeks
19 secondary outcomes
Change From Baseline in 6-Minute Walk Distance (6MWD) Measured Post-Dose
Time frame: Up to 104 weeks
Absolute Change From Baseline in Forced Vital Capacity (FVC)
Time frame: Up to 104 weeks
Percent Change From Baseline in Forced Vital Capacity (FVC)
Time frame: Up to 104 weeks
Absolute Change From Baseline in Percent Predicted FVC (FVC% pred)
Time frame: Up to 104 weeks
Percent Change From Baseline in Percent Predicted FVC (FVC% pred)
Time frame: Up to 104 weeks
Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Up to 104 weeks
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Up to 104 weeks
Absolute Change From Baseline in Percent Predicted FEV1 (FEV1%)
Time frame: Up to 104 weeks
Percent Change From Baseline in Percent Predicted FEV1 (FEV1%)
Time frame: Up to 104 weeks
Change From Baseline in the Plasma Concentration of N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP)
Time frame: Up to 104 weeks
Annualized Rate of Occurrence of Exacerbations of Interstitial Lung Disease (ILD)
Time frame: Up to 104 weeks
Percentage of Participants With a Clinical Worsening Events
Time frame: Up to 104 weeks
Mean Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Domain Score
Time frame: Up to 104 weeks
Mean Change From Baseline in L-PF Cough Domain Score
Time frame: Up to 104 weeks
Mean Change From Baseline in L-PF Dyspnea Domain Score
Time frame: Up to 104 weeks
Mean Change From Baseline in L-PF Impact Domain Score
Time frame: Up to 104 weeks
Mean Change From Baseline in the EuroQoL- 5 Dimensions (EQ-5D-5L) Index Score
Time frame: Up to 104 weeks
Mean Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS)
Time frame: Up to 104 weeks
Percentage of Participants With Major Morbidity or Mortality Events
Time frame: Up to 104 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Insmed Incorporated
11 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Treprostinil Palmitil Inhalation Powder in people with Pulmonary Hypertension and Interstitial Lung Disease, run by Insmed Incorporated at 11 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Germany, Japan, Czechia, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Insmed Incorporated (18444467633, medicalinformation@insmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to 108 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.