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Clinical Trials in the USA / NCT05649748
Active, not recruiting Phase 2/3

An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)

NCT05649748 · tracked via the Priya Life Science USA tracker
Sponsor
Insmed Incorporated
Phase
Phase 2/3
Started
2023-03-07
Last updated
2026-08-20

Condition(s) studied

Pulmonary Arterial Hypertension

Investigational drug(s) / intervention(s)

Treprostinil PalmitilPlacebo

Treprostinil Palmitil: Administered by oral inhalation, using a Plastiape capsule-based dry powder inhaler.

Placebo: Administered by oral inhalation using a Plastiape capsule-based dry powder inhaler

Study summary

The primary purpose of the study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PAH from studies INS1009-201 (NCT04791514), INS1009-202 (NCT05147805) and other lead-in studies of TPIP in participants with PAH.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Male and female participants who completed end of treatment study visit in Study INS1009-201, INS1009-202, or any other lead-in PAH TPIP study. Participants for whom the OLE study was not available at the time of their completion of the lead-in study are eligible for enrolment within one year of their lead-in end of treatment visit. * Complete baseline screening assessments to confirm eligibility to participate if more than 30 days have elapsed since the end of the study visit in Study INS1009-201, INS1009-202, or any other lead-in PAH TPIP study. Exclusion Criteria: * Initiation of parenteral administration of prostacyclin analogues (eg, TRE, epoprostenol) since the completion of studies INS1009-201, INS1009-202 or other TPIP studies. Initiation of inhaled prostacyclin analogues (eg, TRE \[Tyvaso\] or iloprost) and oral prostacyclin analogues (eg, TRE \[Orenitram\]) or receptor agonists (eg, selexipag) are permitted if stopped 24 hours prior to the start of study drug administration. * Any new ventricular or supraventricular tachyarrhythmia except for paroxysmal atrial fibrillation and any new symptomatic bradycardia. * New-onset of heart disease including left ventricular ejection fraction (LVEF) ≤40% or clinically significant valvular, constrictive, or symptomatic atherosclerotic heart disease (eg, stable angina, myocardial infarction, etc). * New evidence of thromboembolic disease as assessed by ventilation/perfusion (VQ) scan, pulmonary angiography, or pulmonary computed tomography (CT) scan. * Active and current symptomatic coronavirus disease 2019 (COVID-19) or previous severe disease and/or hospitalization due to COVID-19. * Interval organ transplantation. * New active liver disease or hepatic dysfunction. * Interval malignancy with exception of completely treated in situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin. * Use of any investigational drug/device or participation in any investigational study within 30 days prior to screening, not including TPIP of the lead-in study. * Current use of cigarettes (as defined by Centers for Disease Control and Prevention \[CDC\]) or e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime, who smokes either every day or some days. * Participants who currently inhale marijuana (recreational or medical). Note: Other inclusion/exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (45)

FacilityCityRegionStatus
USA005 Jacksonville Florida
USA011 Tampa Florida
USA006 Chicago Illinois
USA001 Chicago Illinois
USA102 New York New York
USA016 Dallas Texas
ARG009 Quilmes Buenos Aires
ARG006 Rosario Santa Fe Province
ARG007 San Miguel de Tucumán Tucumán Province
ARG004 Córdoba Argentina
ARG001 Córdoba Argentina
AUT002 Linz Upper Austria
AUT001 Vienna Austria
BEL003 Brussels Belgium
BRA004 Belo Horizonte Minas Gerais
BRA006 Porto Alegre Rio Grande do Sul
BRA002 Blumenau Santa Catarina
DNK001 Aarhus Central Jutland
GER005 Heidelberg Baden-Wurttemberg
GER003 München Bavaria
GER002 Lübeck Schleswig-Holstein
ITA002 Pavia Lombardy
ITA005 Monza Italy
ITA001 Palermo Italy
ITA004 Roma Italy
JPN005 Sapporo Hokkaido
JPN004 Sapporo Hokkaido
JPN007 Kurume-shi Hukuoka
JPN006 Tsukuba Ibaraki
JPN002 Okayama Okayama-ken
JPN003 Suita-Shi Osaka
MYS005 Alor Star Kedah
MYS002 Kuantan Pahang
MYS004 Sungai Buloh Selangor
MEX005 Lomas de Guevara Jalisco
MEX001 Monterrey Nuevo León
MEX003 Mexico City Mexico
MEX004 San Luis Potosí City Mexico
PHL001 Quezon City National Capital Region
PHL002 Makati City Philippines

+ 5 more sites — see the full list on the official registry below.

Official registry record

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.

View NCT05649748 on ClinicalTrials.gov ↗ ← All trials in the USA