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Tests treatment safety and results for Pulmonary Arterial Hypertension
Official title A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)
ClinicalTrials.gov ID: NCT07481981
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 arterial 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 compared with placebo on exercise capacity in adults with PAH.
- 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 to 75
You may be able to join if
- Participants must have a diagnosis of World Health Organisation (WHO) Group 1 pulmonary hypertension (PAH) in any of the following subtypes, in...
- Idiopathic PAH
- Heritable PAH
- Drug/toxin-induced PAH
- Connective tissue disease (CTD)-associated PAH
You likely can't join if
- Diagnosis of PH WHO Groups 2, 3, 4, or 5, or subtypes of PH WHO Group 1 other than described in inclusion criterion 2 (eg, human immunodeficiency...
- Clinically significant left heart disease, including left-sided valvular disease, left ventricular systolic or diastolic dysfunction...
- Evidence of airflow obstruction defined by forced expiratory volume in 1 second (FEV1) per forced vital capacity (FVC) \<0.7.
- Evidence of significant restrictive lung disease as evidenced by FVC \<70% predicted normal.
- 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).
See the full eligibility criteria
- Participants must have a diagnosis of World Health Organisation (WHO) Group 1 pulmonary hypertension (PAH) in any of the following subtypes, in accordance with European Society of Cardiology European Respiratory Society...
- Idiopathic PAH
- Heritable PAH
- Drug/toxin-induced PAH
- Connective tissue disease (CTD)-associated PAH
- PAH associated with congenital heart disease-related to simple systemic-to-pulmonary shunt at least 1 year following repair.
- PAH diagnosis for at least 3 months prior to Screening.
- New York Heart Association (NYHA) or World Health Organization (WHO) functional class II-IV.
- Participants must be on stable PAH therapy consisting of 1 to 3 medications from the following classes:
- Endothelin receptor antagonists (eg, ambrisentan, bosentan, macitentan) for at least 90 days prior to Screening with the last 30 days on stable dose
- Phosphodiesterase type 5 inhibitors (eg, sildenafil, tadalafil) for at least 90 days prior to Screening with the last 30 days on stable dose
- Guanylate cyclase stimulator (eg, riociguat) for at least 90 days prior to Screening with the last 30 days on stable dose
- Activin signaling inhibitor (e.g., sotatercept) for at least 6 months prior to Screening, with the last 3 months on stable dose and meeting all the following conditions:
- no active clinically significant bleeding (eg, epistaxis and gingival bleeding requiring medical interventions) within the past 3 months.
- no history of major bleeding events or risks (eg, gastrointestinal or intracranial bleeding) within the past 6 months.
- platelet counts ≥100,000 per microlitre (μL) at Screening
- For both 6-minute walk tests (6MWTs), the values of 6-minute walk distance (6MWD) should be ≥ 150 and ≤ 450 meters at Screening.
- Right heart catheterization (RHC) at Screening (or within 6 months prior to Screening, if available). Prior RHC may be used provided there has been no change in background PAH therapy and doses. The RHC must meet all of...
- Mean pulmonary arterial pressure (PAP) \>20 millimetre of mercury (mmHg) at rest.
- pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) ≤15 mmHg.
- pulmonary vascular resistance (PVR) of ≥5 wood units (WU).
- Diagnosis of PH WHO Groups 2, 3, 4, or 5, or subtypes of PH WHO Group 1 other than described in inclusion criterion 2 (eg, human immunodeficiency virus (HIV), complex congenital heart disease-associated PAH, portal...
- Clinically significant left heart disease, including left-sided valvular disease, left ventricular systolic or diastolic dysfunction, echocardiographic findings suggestive of post-capillary pulmonary hypertension...
- Evidence of airflow obstruction defined by forced expiratory volume in 1 second (FEV1) per forced vital capacity (FVC) \<0.7.
- Evidence of significant restrictive lung disease as evidenced by FVC \<70% predicted normal.
- 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).
- 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
- Santa Barbara, California, United States
- Anderson, South Carolina, United States
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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Barbara, California, United States; Anderson, South Carolina, United States. 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.