Pulmonary HypertensionPhase 2NCT05176951
A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
A Phase 2 study testing Treprostinil Palmitil in people with Pulmonary Hypertension, run by Insmed Incorporated at 25 sites in 7 countries.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of treprostinil palmitil inhalation powder (TPIP) compared with placebo Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Treprostinil Palmitil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 25 sitesin 7 countries
- Study dates
- 22 Dec 2022to 14 Mar 2024
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females must be ≥ 18 to ≤ 80 years of age at the time of signing the informed consent form (ICF).
- Diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD) (including idiopathic interstitial pneumonia [IIP], idiopathic pulmonary fibrosis [IPF], connective tissue disease [CTD], sarcoidosis).
- Male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Male participants:
- Male participants who are not sterile, with female partners of childbearing potential, must be using effective contraception from Day 1 to at least 90 days after the last dose of study drug.
- Male participants with women of child bearing potential (WOCBP) partner must use a condom in order to avoid potential exposure to embryo/fetus.
- Female participants: Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, (ie,hysterectomy and/or bilateral salpingo-oophorectomy) or using highly effective contraception methods (ie, methods that alone or in combination achieve <1% unintended pregnancy rates per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose of study drug.
- Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Who cannot join
- Primary diagnosis of chronic obstructive pulmonary disease (COPD).
- Allergy, or documented hypersensitivity or contraindication to TPIP or treprostinil (TRE) or mannitol (an excipient of the TPIP formulation).
- Received or currently treated with riociguat, endothelin receptor antagonists, selexipag, phosphodiesterase 5 (PDE5) inhibitors and/or prostacyclin analogues within 30 days prior to Screening.
- Started therapy with pirfenidone or nintedanib < 90 days prior to Screening, OR, if already receiving either medication, there is a dose change within 30 days of Screening Visit.
- Any known ventricular or supraventricular tachyarrhythmia (except for paroxysmal atrial fibrillation), and/or any symptomatic bradycardia.
- History of heart disease including left ventricular ejection fraction (LVEF) ≤ 40% or clinically significant valvular, constrictive, or symptomatic atherosclerotic heart disease (eg, stable angina, myocardial infarction, etc).
Show all 17Show fewer
- Participation in a cardiopulmonary rehabilitation program within 30 days of the first Screening Visit. Participation in the maintenance program of a cardiopulmonary rehabilitation program is allowed.
- Acutely decompensated heart failure within 30 days of Screening Visit.
- Active and current symptomatic coronavirus disease 2019 (COVID-19) and/or previous diagnosis of moderate to severe disease, or hospitalization due to COVID-19.
- Supplemental oxygen requirement > 10L/min at rest at Screening.
- Exacerbation of underlying lung disease or active pulmonary or upper respiratory infection within 30 days of the first dose of study drug (may be rescreened at appropriate time).
- Current or recent (past 30 days) lower respiratory tract infection (may be rescreened at appropriate time).
- Any form of congenital heart disease or congenital heart defect (repaired or unrepaired) other than a patent foramen ovale.
- History of alcohol or drug abuse within 6 months prior to Screening.
- Current use of cigarettes (as defined by Center for Disease Control (CDC)) or e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime and who currently smokes either every day or some days.
- Participants who currently inhale marijuana (recreational or medical).
- Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements, in particular with 6-minute walk test (6MWT) (eg, angina pectoris, claudication, musculoskeletal disorder, need for walking aids).
Trial locations and contacts
25 sites in 7 countries.
25 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
Munich, 81377
Spain6 sites
ESP010
Barcelona, 08035
ESP005
Barcelona, 08907
ESP006
Las Palmas de Gran Canaria, 35010
ESP007
Oviedo, Principality of Asturias, 33011
ESP003
Palma de Mallorca, Balearic Islands, 07120
ESP009
Santiago de Compostela, 15706
Italy4 sites
ITA004
Milan, Lombardy, 20123
ITA002
Monza, Lombardy, 20900
ITA003
Naples, Campania, 80131
ITA001
Palermo, Sicily, 90127
Argentina3 sites
ARG003
Barracas, Ciudad Autónoma de BuenosAires, C1280AEB
ARG008
Buenos Aires, CI094AAD
ARG001
Rosario, Santa Fe Province, S2013KDS
Australia2 sites
AUS003
Camperdown, New South Wales, 2050
AUS005
Macquarie Park, New South Wales, 2109
United Kingdom2 sites
GBR003
Glasgow, Lanarkshire, G81 4HX
GBR001
Sheffield, Yorkshire, S10 2JF
About this study
Official title: A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Tolerability 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 treprostinil palmitil inhalation powder (TPIP) compared with placebo
- Conditions
- Pulmonary Hypertension
- Being tested
- Treprostinil Palmitil, Placebo
- Keywords
- Pulmonary Hypertension, Interstitial Lung Disease, 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 PalmitilDrug
Also called INS1009
Oral inhalation using a capsule-based dry powder inhaler device.
PlaceboDrug
Oral inhalation using a capsule-based dry powder inhaler device.
| Study group | Role | What they receive |
|---|---|---|
| Treprostinil Palmitil | Experimental | Participants will be administered TPIP once per day at a starting dose of 80 micrograms (μg). Participants will be titrated up to the highest tolerated dose for each individual participant of between 80 μg and 640 μg during the initial 3 weeks of treatment. The overall treatment period will be 16 weeks. Receives: Drug: Treprostinil Palmitil |
| Placebo | Placebo comparator | Participants will be administered a placebo matching TPIP once daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience Any Number of Treatment Emergent Adverse Events (TEAEs)
Measured: Up to Day 140
Number of Participants Who Experience Any Number of Serious Adverse Events (SAEs)
Measured: Up to Day 140
Change from Baseline in Saturation of Peripheral Capillary Oxygenation (SpO2) Levels
Measured: Pre-, during, and post- 6-minute walk test (6MWT) at Baseline, Week 5, Week 10, and Week 16
Secondary outcomes (16)
Maximum Plasma Concentration (Cmax) of Treprostinil Palmitil
Measured: Day 1 to Week 16
Cmax of Treprostinil
Measured: Day 1 to Week 16
Time to Maximum Plasma Concentration (Tmax) of Treprostinil Palmitil
Measured: Day 1 to Week 16
Tmax of Treprostinil
Measured: Day 1 to Week 16
Area Under Concentration-time Curve From Time 0 to 24 Hours Post-dose (AUCtau) of Treprostinil Palmitil
Measured: Day 1 to Week 16
AUCtau of Treprostinil
Measured: Day 1 to Week 16
Area Under Concentration-time Curve From 0 to Infinity (AUC∞) of Treprostinil Palmitil
Measured: Day 1 to Week 16
AUC∞ of Treprostinil
Measured: Day 1 to Week 16
Area Under Concentration-time Curve From Time 0 to Last Measurable Concentration (AUClast) of Treprostinil Palmitil
Measured: Day 1 to Week 16
AUClast of Treprostinil
Measured: Day 1 to Week 16
Apparent Total Clearance (CL/F) of Treprostinil Palmitil
Measured: Day 1 to Week 16
CL/F of Treprostinil
Measured: Day 1 to Week 16
Elimination Half-life (t1/2) of Treprostinil Palmitil
Measured: Day 1 to Week 16
t1/2 of Treprostinil
Measured: Day 1 to Week 16
Apparent Volume of Distribution After Terminal Phase (Vd/F) of Treprostinil Palmitil
Measured: Day 1 to Week 16
Vd/F of Treprostinil
Measured: Day 1 to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start22 Dec 2022
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 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
- NCT05176951
- Sponsor's protocol ID
- INS1009-211
- Other IDs
- 2021-003294-66
- Status last verified
- Mar 2025
- First submitted
- 10 Dec 2021
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT05176951
- Acronym / sponsor ID
- INS1009-211
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension, Interstitial Lung Disease, Treprostinil Palmitil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 4 Jan 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 treprostinil palmitil inhalation powder (TPIP) compared with placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treprostinil Palmitil | Experimental | Drug: Treprostinil PalmitilParticipants will be administered TPIP once per day at a starting dose of 80 micrograms (μg). Participants will be titrated up to the highest tolerated dose for each individual participant of between 80 μg and 640 μg during the initial 3 weeks of treatment. The overall treatment period will be 16 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be administered a placebo matching TPIP once daily. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females must be ≥ 18 to ≤ 80 years of age at the time of signing the informed consent form (ICF).
- Diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD) (including idiopathic interstitial pneumonia [IIP], idiopathic pulmonary fibrosis [IPF], connective tissue disease [CTD], sarcoidosis).
- Male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Male participants:
- Male participants who are not sterile, with female partners of childbearing potential, must be using effective contraception from Day 1 to at least 90 days after the last dose of study drug.
Key exclusion criteria (17 listed)
- Primary diagnosis of chronic obstructive pulmonary disease (COPD).
- Allergy, or documented hypersensitivity or contraindication to TPIP or treprostinil (TRE) or mannitol (an excipient of the TPIP formulation).
- Received or currently treated with riociguat, endothelin receptor antagonists, selexipag, phosphodiesterase 5 (PDE5) inhibitors and/or prostacyclin analogues within 30 days prior to Screening.
- Started therapy with pirfenidone or nintedanib < 90 days prior to Screening, OR, if already receiving either medication, there is a dose change within 30 days of Screening Visit.
- Any known ventricular or supraventricular tachyarrhythmia (except for paroxysmal atrial fibrillation), and/or any symptomatic bradycardia.
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 PalmitilAlso: INS1009Oral inhalation using a capsule-based dry powder inhaler device. | Drug | Treprostinil Palmitil |
| PlaceboOral inhalation using a capsule-based dry powder inhaler device. | Drug | Placebo |
Primary outcome
Number of Participants Who Experience Any Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Day 140
Number of Participants Who Experience Any Number of Serious Adverse Events (SAEs)
Time frame: Up to Day 140
Change from Baseline in Saturation of Peripheral Capillary Oxygenation (SpO2) Levels
Time frame: Pre-, during, and post- 6-minute walk test (6MWT) at Baseline, Week 5, Week 10, and Week 16
16 secondary outcomes
Maximum Plasma Concentration (Cmax) of Treprostinil Palmitil
Time frame: Day 1 to Week 16
Cmax of Treprostinil
Time frame: Day 1 to Week 16
Time to Maximum Plasma Concentration (Tmax) of Treprostinil Palmitil
Time frame: Day 1 to Week 16
Tmax of Treprostinil
Time frame: Day 1 to Week 16
Area Under Concentration-time Curve From Time 0 to 24 Hours Post-dose (AUCtau) of Treprostinil Palmitil
Time frame: Day 1 to Week 16
AUCtau of Treprostinil
Time frame: Day 1 to Week 16
Area Under Concentration-time Curve From 0 to Infinity (AUC∞) of Treprostinil Palmitil
Time frame: Day 1 to Week 16
AUC∞ of Treprostinil
Time frame: Day 1 to Week 16
Area Under Concentration-time Curve From Time 0 to Last Measurable Concentration (AUClast) of Treprostinil Palmitil
Time frame: Day 1 to Week 16
AUClast of Treprostinil
Time frame: Day 1 to Week 16
Apparent Total Clearance (CL/F) of Treprostinil Palmitil
Time frame: Day 1 to Week 16
CL/F of Treprostinil
Time frame: Day 1 to Week 16
Elimination Half-life (t1/2) of Treprostinil Palmitil
Time frame: Day 1 to Week 16
t1/2 of Treprostinil
Time frame: Day 1 to Week 16
Apparent Volume of Distribution After Terminal Phase (Vd/F) of Treprostinil Palmitil
Time frame: Day 1 to Week 16
Vd/F of Treprostinil
Time frame: Day 1 to Week 16
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 17 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Hypertension
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A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
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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.
25 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Treprostinil Palmitil in people with Pulmonary Hypertension, run by Insmed Incorporated at 25 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 8 inclusion and 17 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 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Germany, Spain, Italy, Argentina, Australia 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Experience Any Number of Treatment Emergent Adverse Events (TEAEs) (time frame: Up to Day 140). The study lists 3 primary outcomes in all. 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 17 Mar 2025.