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Looking for participantsPhase3

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

Sponsor: Insmed Incorporated

NCT ID: NCT07179380

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Treprostinil Palmitil Inhalation Powder (drug), Placebo (drug)
How long the study runs
Study runs about 35 months (dates as stated)
About the drug or intervention
Treprostinil Palmitil Inhalation Powder — drug: Oral inhalation using a capsule-based dry powder inhaler device. · Placebo — drug: Oral inhalation using a capsule-based dry powder inhaler device.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
344
Started
2026-01-07
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for pulmonary hypertension
  • • Phase3 - 344 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with pulmonary hypertension

Where?

  • • London - GBR009
  • • Sheffield - GBR004
  • • Bath - GBR001
  • • Belfast - GBR008
  • • +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Pulmonary HypertensionInterstitial Lung Disease

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Inclusion Criteria
  • ✓Confirmation of fibrotic interstitial lung disease by centrally overread computed tomography (CT) scan performed at...
  • ✓PH confirmed by right heart catheterization (RHC) at Screening or within 12 months prior to Screening, with the...
  • ✓Mean lung arterial pressure (mPAP) \>20 millimetre of mercury (mmHg) and
  • ✓lung capillary wedge pressure (PCWP) of ≤15 mmHg and
See the full criteria
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 6 minute walking test (6MWT)s 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 (including sarcoidosis), 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)/ forced vital capacity (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% * echocardiography findings at Screening suggestive for postcapillary (or combined pre and postcapillary) PH, heart failure with preserved ejection fraction (HFpEF), or heart failure with mildly reduced ejection fraction (HFmrEF), including left atrial volume index (LAVI) \>34 millilitres per metre square (mL/m\^2) * 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.

Where Is This Study? (9 UK sites)

GBR009

London W12 0HS, United Kingdom

NOT_YET_RECRUITING

GBR004

Sheffield S10 2JF, United Kingdom

Recruiting

GBR001

Bath BA1 3NG, United Kingdom

NOT_YET_RECRUITING

GBR008

Belfast BT9 7AB, United Kingdom

NOT_YET_RECRUITING

GBR007

Glasgow G81 4DY, United Kingdom

NOT_YET_RECRUITING

GBR002

London NW3 2QG, United Kingdom

NOT_YET_RECRUITING

GBR003

London SW3 6NP, United Kingdom

NOT_YET_RECRUITING

GBR010

Salford M6 8HD, United Kingdom

NOT_YET_RECRUITING

GBR005

Southampton SO16 6YD, United Kingdom

NOT_YET_RECRUITING

How to Get in Touch

Insmed Medical Information

Sponsor contact

CONTACT

18444467633 medicalinformation@insmed.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09