Pulmonary HypertensionPhase 2/3NCT05649722
An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
A Phase 2/3 study testing Treprostinil Palmitil Inhalation Powder in people with Pulmonary Hypertension and Interstitial Lung Disease, run by Insmed Incorporated at 22 sites in 7 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 INS1009-211 (NCT05176951) and other lead-in studies of TPIP in participants with PH-ILD. 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
- 31 participants
- Where
- 22 sitesin 7 countries
- Study dates
- 11 May 2023to 1 Apr 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 completed the end of treatment visit in Study INS1009-211 (NCT05176951). Participants for whom the OLE study was not available at the time of their completion of the lead-in study are eligible for enrolment within one year of their lead-in end of treatment visit.
- Complete baseline screening assessments to confirm eligibility to participate if more than 30 days have elapsed since the end of the study visit in Study INS1009-211, or any other lead-in PH-ILD TPIP study.
- 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.
Who cannot join
- Participants who experienced any hypersensitivity or adverse drug reaction or were withdrawn early/discontinued in a previous PH-ILD TPIP study, which in the opinion of the Investigator, could indicate that continued treatment with TPIP may present an unreasonable risk for the participant.
- Initiation of parenteral administration of prostacyclin analogues (eg, TRE, epoprostenol) since the completion of Study INS1009-211 or other TPIP studies. Initiation of inhaled prostacyclin analogues (eg, TRE [Tyvaso] or iloprost) and oral prostacyclin analogues (eg, TRE [Orenitram]) or receptor agonists (eg, selexipag) are permitted if stopped 24 hours prior to the start of study drug administration.
- Pregnant or breastfeeding. Male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants of childbearing potential must have a negative urine pregnancy test result at trial entry before the first dose of study drug.
- Any medical or psychological condition, including relevant laboratory abnormalities at screening that, in the opinion of the Investigator, suggest a new and/or insufficiently understood disease that may present an unreasonable risk to the study participant as a result of participation in the study.
Trial locations and contacts
22 sites in 7 countries.
22 sites in 7 countries
Germany7 sites
GER002
Berlin, 13125
GER012
Berlin, 14050
GER001
Dresden, Saxony, 01307
GER003
Essen, North Rhine-Westphalia, 45239
GER010
Giessen, Hesse, 35392
GER006
Heidelberg, Baden-Wurttemberg, 69126
GER004
München, Bavaria, 81377
Spain5 sites
ESP005
Barcelona, 08907
ESP010
Barcelona, 8035
ESP007
Oviedo, Principality of Asturias, 33011
ESP003
Palma, Balearic Islands, 07120
ESP009
Santiago de Compostela, Galicia, 15706
Italy4 sites
ITA004
Milan, Lombardy, 20123
ITA002
Monza, Lombardy, 20900
ITA003
Naples, 80131
ITA001
Palermo, Sicily, 90127
Argentina2 sites
ARG003
Autonomus City of Buenos Aires, Buenos Aires, C1280AEB
ARG001
Rosario, Santa Fe Province, S2013KDS
United Kingdom2 sites
GBR003
Clydebank, Glasgow, G81 4DY
GBR001
Sheffield, South Yorkshire, S10 2JF
About this study
Official title: An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term Use of Treprostinil Palmitil Inhalation Powder in Participants With 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 INS1009-211 (NCT05176951) and other lead-in studies of TPIP in participants with PH-ILD.
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease
- Being tested
- Treprostinil Palmitil Inhalation Powder, Placebo
- Keywords
- Treprostinil Palmitil
- 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 inhaler device.
PlaceboDrug
Oral placebo inhalation using a capsule-based dry powder inhaler device.
| Study group | Role | What they receive |
|---|---|---|
| Treprostinil Palmitil Inhalation Powder | Experimental | Participants who are not transitioning immediately from INS1009-211 and other lead-in studies, will be administered TPIP, once daily (QD), during 3-week titration period.
Participants who are transitioning immediately from a randomized blinded lead-in TPIP study and who previously received:
1. TPIP- will be administered placebo QD along with the maximum tolerated dose (MTS) TPIP dose from lead-in study in a blinded manner during 3-week titration period.
2. Placebo- will be administered TPIP QD along with the achieved placebo dose from lead-in study in a blinded manner during 3-week titration period.
The overall treatment period will be 24 months. 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 a Treatment Emergent Adverse Event (TEAE)
Measured: Up to approximately 25 months
Secondary outcomes (15)
Absolute Change From Pre-Open-Label Extension (OLE) Baseline in 6-Minute Walk Distance (6MWD)
Measured: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Relative Change From Pre-OLE Baseline in 6-MWD
Measured: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Change From Pre-OLE Baseline in Forced Vital Capacity (FVC)
Measured: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Change From Pre-OLE Baseline in Percent Predicted FVC (FVC%)
Measured: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Change From Pre-OLE Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Measured: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Change From Pre-OLE Baseline in Percent Predicted FEV1 (FEV1%)
Measured: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Change From Pre-OLE Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75%)
Measured: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Absolute Change From Pre-OLE Baseline in Lung Diffusion Capacity for Carbon Monoxide (DLCO)
Measured: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 12 and 24
Relative Change From Pre-OLE Baseline in Lung DLCO
Measured: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 12 and 24
Change From Pre-OLE Baseline in the Concentration of N-Terminal Fragment B-Type Natriuretic Peptide (NT-proBNP) in Blood
Measured: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Annualized Rate of Clinical Worsening Events Based on Percentage of Participants With Clinical Worsening Events
Clinical worsening events are defined as one of the following: Hospitalization due to a cardiopulmonary indication; Lung transplantation; Death from any cause; Decrease in 6MWD ≥ 15% from baseline; Directly related to disease under study, at 2 consecutive visits at least 24 hours apart; Need for additional pulmonary hypertension (PH) therapy. Annualized clinical worsening event rate is defined as the total number of clinical worsening events that occurred during the treatment period divided by the total number of participant-years during the treatment period.
Measured: Up to Month 24
Annualized Rate of Occurrence of Acute Exacerbations of Underlying Interstitial Lung Disease (AE-ILDs)
Measured: Up to Month 24
Change From OLE Baseline in the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Score
Measured: OLE Baseline (Day 1) to Months 6, 12, 18, and 24
Change From OLE Baseline in the Euro Quality of Life-5 Dimension-5 Level (EQ-5D-5L) Questionnaire Score
Measured: OLE Baseline (Day 1) to Months 6, 12, 18, and 24
Plasma Concentration Levels of Treprostinil Palmitil (TP) and Treprostinil (TRE)
Measured: OLE Baseline (Day 1), Months 6, 12, 18, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start11 May 2023
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insmed Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649722
- Sponsor's protocol ID
- INS1009-212
- Other IDs
- 2022-001950-45, 2023-505540-19-00, 2023
- Status last verified
- Apr 2026
- First submitted
- 6 Dec 2022
- Last updated
- 23 Apr 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term Use of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT05649722
- Acronym / sponsor ID
- INS1009-212
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease
- Keywords
- Treprostinil Palmitil
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 11 May 2023 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 14 Dec 2022 (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 INS1009-211 (NCT05176951) and other lead-in studies of TPIP in participants with PH-ILD.
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 | Experimental | Drug: Treprostinil Palmitil Inhalation Powder, Drug: PlaceboParticipants who are not transitioning immediately from INS1009-211 and other lead-in studies, will be administered TPIP, once daily (QD), during 3-week titration period. Participants who are transitioning immediately from a randomized blinded lead-in TPIP study and who previously received: 1. TPIP- will be administered placebo QD along with the maximum tolerated dose (MTS) TPIP dose from lead-in study in a blinded manner during 3-week titration period. 2. Placebo- will be administered TPIP QD along with the achieved placebo dose from lead-in study in a blinded manner during 3-week titration period. The overall treatment period will be 24 months. |
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 completed the end of treatment visit in Study INS1009-211 (NCT05176951). Participants for whom the OLE study was not available at the time of their completion of the lead-in study are eligible for enrolment within one year of their lead-in end of treatment visit.
- Complete baseline screening assessments to confirm eligibility to participate if more than 30 days have elapsed since the end of the study visit in Study INS1009-211, or any other lead-in PH-ILD TPIP study.
- 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.
Key exclusion criteria (4 listed)
- Participants who experienced any hypersensitivity or adverse drug reaction or were withdrawn early/discontinued in a previous PH-ILD TPIP study, which in the opinion of the Investigator, could indicate that continued treatment with TPIP may present an unreasonable risk for the participant.
- Initiation of parenteral administration of prostacyclin analogues (eg, TRE, epoprostenol) since the completion of Study INS1009-211 or other TPIP studies. Initiation of inhaled prostacyclin analogues (eg, TRE [Tyvaso] or iloprost) and oral prostacyclin analogues (eg, TRE [Orenitram]) or receptor agonists (eg, selexipag) are permitted if stopped 24 hours prior to the start of study drug administration.
- Pregnant or breastfeeding. Male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants of childbearing potential must have a negative urine pregnancy test result at trial entry before the first dose of study drug.
- Any medical or psychological condition, including relevant laboratory abnormalities at screening that, in the opinion of the Investigator, suggest a new and/or insufficiently understood disease that may present an unreasonable risk to the study participant as a result of participation in the study.
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 inhaler device. | Drug | Treprostinil Palmitil Inhalation Powder |
| PlaceboOral placebo inhalation using a capsule-based dry powder inhaler device. | Drug | Treprostinil Palmitil Inhalation Powder |
Primary outcome
Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)
Time frame: Up to approximately 25 months
15 secondary outcomes
Absolute Change From Pre-Open-Label Extension (OLE) Baseline in 6-Minute Walk Distance (6MWD)
Time frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Relative Change From Pre-OLE Baseline in 6-MWD
Time frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Change From Pre-OLE Baseline in Forced Vital Capacity (FVC)
Time frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Change From Pre-OLE Baseline in Percent Predicted FVC (FVC%)
Time frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Change From Pre-OLE Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Change From Pre-OLE Baseline in Percent Predicted FEV1 (FEV1%)
Time frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Change From Pre-OLE Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75%)
Time frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Absolute Change From Pre-OLE Baseline in Lung Diffusion Capacity for Carbon Monoxide (DLCO)
Time frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 12 and 24
Relative Change From Pre-OLE Baseline in Lung DLCO
Time frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 12 and 24
Change From Pre-OLE Baseline in the Concentration of N-Terminal Fragment B-Type Natriuretic Peptide (NT-proBNP) in Blood
Time frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Annualized Rate of Clinical Worsening Events Based on Percentage of Participants With Clinical Worsening Events
Time frame: Up to Month 24
Annualized Rate of Occurrence of Acute Exacerbations of Underlying Interstitial Lung Disease (AE-ILDs)
Time frame: Up to Month 24
Change From OLE Baseline in the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Score
Time frame: OLE Baseline (Day 1) to Months 6, 12, 18, and 24
Change From OLE Baseline in the Euro Quality of Life-5 Dimension-5 Level (EQ-5D-5L) Questionnaire Score
Time frame: OLE Baseline (Day 1) to Months 6, 12, 18, and 24
Plasma Concentration Levels of Treprostinil Palmitil (TP) and Treprostinil (TRE)
Time frame: OLE Baseline (Day 1), Months 6, 12, 18, and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Treprostinil Palmitil Inhalation Powder in people with Pulmonary Hypertension and Interstitial Lung Disease, run by Insmed Incorporated at 22 sites in 7 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 4 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: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Germany, Spain, Italy, Argentina, United Kingdom and 2 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE) (time frame: Up to approximately 25 months). 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 23 Apr 2026.