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Clinical Trials in the UK / NCT07179380
Recruiting Phase 3

Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

NCT07179380 · tracked via the Priya Life Science UK tracker
Sponsor
Insmed Incorporated
Phase
Phase 3
Started
2026-01-07
Last updated
2026-08-14

Condition(s) studied

Pulmonary HypertensionInterstitial Lung Disease

Investigational drug(s) / intervention(s)

Treprostinil Palmitil Inhalation PowderPlacebo

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.

Study summary

The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP versus placebo on exercise capacity in adults with PH-ILD.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria * Diagnosis of PH World Health Organisation (WHO) Group 3 associated with ILD \[including but not limited to idiopathic interstitial pneumonia (IIP), chronic hypersensitivity pneumonitis (HSP), connective tissue disease-associated interstitial lung disease (CTD-ILD), combined pulmonary fibrosis and emphysema (CPFE)\]. * 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 * Diagnosis of Pulmonary Hypertension WHO Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease. * 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. Note: Other protocol defined inclusion/exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (145)

FacilityCityRegionStatus
USA010 Los Angeles California Not Yet Recruiting
USA001 Santa Barbara California Recruiting
USA017 Gainesville Florida Not Yet Recruiting
USA006 Naples Florida Recruiting
USA026 St. Petersburg Florida Recruiting
USA002 Kansas City Kansas Not Yet Recruiting
USA005 New York New York Not Yet Recruiting
USA015 Cincinnati Ohio Not Yet Recruiting
USA003 Bend Oregon Recruiting
USA013 Philadelphia Pennsylvania Recruiting
USA008 Richmond Virginia Recruiting
ARG005 Ciudad Autónoma de Buenos Aires Buenos Aires Recruiting
ARG002 CiudadAutonoma de Buenos Aires Buenos Aires Recruiting
ARG003 Río Cuarto Córdoba Province Recruiting
ARG008 San Miguel de Tucumán Tucumán Province Recruiting
ARG004 Córdoba Argentina Not Yet Recruiting
ARG001 Córdoba Argentina Not Yet Recruiting
AUS001 Camperdown New South Wales Recruiting
AUS006 Kingswood New South Wales Recruiting
AUS005 New Lambton Heights New South Wales Recruiting
AUS003 Westmead New South Wales Not Yet Recruiting
AUS002 South Brisbane Queensland Not Yet Recruiting
AUT002 Innsbruck Austria Not Yet Recruiting
BEL002 Leuven Vlaams Brabant Recruiting
BEL001 Anderlecht Belgium Recruiting
BRA012 Porto Alegre Rio Grande do Sul Recruiting
BRA007 Porto Alegre Rio Grande do Sul Not Yet Recruiting
BRA003 Porto Alegre Rio Grande do Sul Not Yet Recruiting
CZE001 Prague Czechia Recruiting
DNK001 Aarhus N Central Jutland Recruiting
FRA009 Nice Alpes-Maritimes Recruiting
FRA002 Marseille Bouches-du-Rhône Recruiting
FRA004 Angers Maine-et-Loire Recruiting
FRA007 Lille Nord Not Yet Recruiting
FRA008 Saint Priest En Jarez Pays de la Loire Region Not Yet Recruiting
FRA003 Le Kremlin-Bicêtre Val-de-Marne Recruiting
FRA001 Poitiers Vienne Recruiting
FRA010 Brest France Not Yet Recruiting
FRA011 Bron France Not Yet Recruiting
FRA005 Pessac France Recruiting

+ 105 more sites — see the full list on the official registry below.

More Insmed Incorporated trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07179380 on ClinicalTrials.gov ↗ ← All trials in the UK