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Tests treatment safety and results for Pulmonary Hypertension
Official title Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
ClinicalTrials.gov ID: NCT07179380
What this study is testing
What is Treprostinil Palmitil Inhalation Powder?
Treprostinil Palmitil Inhalation Powder is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for pulmonary hypertension.
Also referred to as INS1009.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of PH World Health Organisation (WHO) Group 3 associated with ILD [including but not limited to idiopathic interstitial pneumonia (IIP)...
- Confirmation of fibrotic interstitial lung disease by centrally overread computed tomography (CT) scan performed at Screening or within prior 12...
- 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
You likely can't join 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...
- 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
See the full eligibility 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...
- 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...
- 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Santa Barbara, California, United States
- Naples, Florida, United States
- St. Petersburg, Florida, United States
- Kansas City, Kansas, United States
- Bend, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Richmond, Virginia, United States
- CiudadAutonoma de Buenos Aires, Buenos Aires, Argentina
- Río Cuarto, Córdoba Province, Argentina
- San Miguel de Tucumán, Tucumán Province, Argentina
- Córdoba, Argentina
- Camperdown, New South Wales, Australia
- Kingswood, New South Wales, Australia
- New Lambton Heights, New South Wales, Australia
- Westmead, New South Wales, Australia
- Innsbruck, Austria
- Leuven, Vlaams Brabant, Belgium
- Anderlecht, Belgium
- Prague, Czechia
+ 76 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Santa Barbara, California, United States; Naples, Florida, United States; St. Petersburg, Florida, United States; Kansas City, Kansas, United States; Bend, Oregon, United States and 90 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.