RecruitingPulmonary HypertensionInterstitial Lung Disease
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Eligible age
18+ yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Insmed Incorporated
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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)
Where it's recruiting
California
Los Angeles · Santa Barbara
Florida
Naples · St. Petersburg
Kansas
Kansas City
Oregon
Bend
Pennsylvania
Philadelphia
Virginia
Richmond
Source: ClinicalTrials.gov · NCT07179380 · last updated 2026-05-27