Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
NCT ID: NCT07179380
Last Updated: 2026-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
344 participants
INTERVENTIONAL
2026-01-07
2028-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treprostinil Palmitil Inhalation Powder
Participants will receive TPIP, once daily (QD), at a starting dose of 80 micrograms (μg) to maximum tolerated dose up to 1280 μg for 24 weeks.
Treprostinil Palmitil Inhalation Powder
Oral inhalation using a capsule-based dry powder inhaler device.
Placebo
Participants will receive a placebo matching TPIP QD for 24 weeks.
Placebo
Oral inhalation using a capsule-based dry powder inhaler device.
Interventions
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Treprostinil Palmitil Inhalation Powder
Oral inhalation using a capsule-based dry powder inhaler device.
Placebo
Oral inhalation using a capsule-based dry powder inhaler device.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmation of fibrotic interstitial lung disease by centrally overread computed tomography (CT) scan performed at Screening or within prior 12 months.
* PH confirmed by right heart catheterization (RHC) at Screening or within 12 months prior to Screening, with the following hemodynamic findings:
* Mean pulmonary arterial pressure (mPAP) \>20 millimetre of mercury (mmHg) and
* Pulmonary capillary wedge pressure (PCWP) of ≤15 mmHg and
* Pulmonary vascular resistance (PVR) ≥4 wood units (WU).
* 6 Minute walking distance (6MWD) ≥100 and ≤500 meters at two 6MWTs at Screening performed at least 4 hours apart, with the difference between the 2 distances ≤15%.
* Participants receiving chronic medication for underlying disease (e.g., antifibrotic, immunomodulators, immunosuppressants, etc.) and/or phosphodiesterase 5 (PDE5) inhibitors, should be on this treatment for ≥90 days and on a stable dose for ≥30 days prior to Screening.
* Capable of giving signed informed consent as described in Section 10.1.5 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria
* Primary diagnosis of chronic obstructive pulmonary disease (COPD) and/or forced expiratory volume in 1 second (FEV1)/FVC \<0.7 (based on screening or historical spirometry within the prior 6 months).
* Clinically significant left heart disease:
* evidence of clinically significant left-sided valvular heart disease,
* left ventricular failure with left ventricular ejection fraction (LVEF) \<45%, or diagnosis of heart failure with preserved ejection fraction (HFpEF)
* echocardiography findings at Screening suggestive for postcapillary PH
* unstable ischemic heart disease
* unstable arrhythmia, including uncontrolled atrial fibrillation (rate-controlled arrhythmia or paroxysmal atrial fibrillation is allowed)
* Evidence of chronic thromboembolic disease or recent (within 6 months of Screening) acute pulmonary embolism.
* Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (e.g., mannitol, leucine).
* Current use of cigarettes 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.
* Current use of inhaled marijuana, recreational or medical (current use defined as used at least one or more times during the past 30 days prior to Screening) or expected use during the study.
* Any other 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 and/or may present an unreasonable risk to the study participant as a result of his/her participation in this clinical trial, may impede their ability complete the study or the study assessments or confound the outcomes of the trial.
18 Years
ALL
No
Sponsors
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Insmed Incorporated
INDUSTRY
Responsible Party
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Locations
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USA001
Santa Barbara, California, United States
USA006
Naples, Florida, United States
USA003
Bend, Oregon, United States
USA008
Richmond, Virginia, United States
GEO004
Tbilisi, , Georgia
GEO003
Tbilisi, , Georgia
GEO001
Tbilisi, , Georgia
ISR003
Petah Tikva, Central District, Israel
ISR001
Haifa, , Israel
ISR002
Jerusalem, , Israel
JPN002
Narashino-shi, Chiba, Japan
JPN001
Sapporo, Hokkaido, Japan
JPN007
Yokohama, Kanagawa, Japan
JPN008
Kiyose, Tokyo, Japan
JPN003
Shibuya City, Tokyo, Japan
JPN005
Nagano, , Japan
Countries
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Central Contacts
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Other Identifiers
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2025-521558-40-00
Identifier Type: OTHER
Identifier Source: secondary_id
INS1009-311
Identifier Type: -
Identifier Source: org_study_id
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