Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
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 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.
Primary outcome measure(s)
Change in 6 Minute Walk Distance (6MWD) Measured at Peak Exposure From Baseline to Week 24 — Baseline, Week 24
Trial sites (185)
Facility
City
Region
Status
USA027
Phoenix
Arizona
Not Yet Recruiting
USA007
Fresno
California
Not Yet Recruiting
USA010
Los Angeles
California
Not Yet Recruiting
USA023
Los Angeles
California
Not Yet Recruiting
USA020
San Francisco
California
Not Yet Recruiting
USA001
Santa Barbara
California
Recruiting
USA017
Gainesville
Florida
Not Yet Recruiting
USA006
Naples
Florida
Recruiting
USA026
St. Petersburg
Florida
Recruiting
USA028
Tampa
Florida
Not Yet Recruiting
USA002
Kansas City
Kansas
Not Yet Recruiting
USA005
New York
New York
Not Yet Recruiting
USA011
Durham
North Carolina
Not Yet Recruiting
USA015
Cincinnati
Ohio
Not Yet Recruiting
USA003
Bend
Oregon
Recruiting
USA013
Philadelphia
Pennsylvania
Recruiting
USA025
Salt Lake City
Utah
Not Yet Recruiting
USA008
Richmond
Virginia
Recruiting
ARG010
Ciudad Autónoma de Buenos Aires
Buenos Aires
Not Yet Recruiting
ARG005
Ciudad Autónoma de Buenos Aires
Buenos Aires
Recruiting
ARG002
CiudadAutonoma de Buenos Aires
Buenos Aires
Recruiting
ARG003
Río Cuarto
Córdoba Province
Recruiting
ARG011
Rosario
Santa Fe Province
Not Yet Recruiting
ARG008
San Miguel de Tucumán
Tucumán Province
Recruiting
ARG004
Córdoba
Argentina
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
Recruiting
AUS004
Auchenflower
Queensland
Not Yet Recruiting
AUS002
South Brisbane
Queensland
Not Yet Recruiting
AUT002
Innsbruck
Austria
Not Yet Recruiting
AUT001
Linz
Austria
Not Yet Recruiting
AUT003
Vienna
Austria
Not Yet Recruiting
BEL002
Leuven
Vlaams Brabant
Recruiting
BEL001
Anderlecht
Belgium
Recruiting
BRA001
Belo Horizonte
Minas Gerais
Recruiting
BRA012
Porto Alegre
Rio Grande do Sul
Recruiting
BRA007
Porto Alegre
Rio Grande do Sul
Not Yet Recruiting
+ 145 more sites — see the full list on the official registry below.
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.
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