An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)
NCT ID: NCT05649748
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
91 participants
INTERVENTIONAL
2023-03-07
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treprostinil Palmitil Inhalation Powder (TPIP)
Participants who are not transitioning immediately from other TPIP studies:INS1009-201(NCT04791514), INS1009-202(NCT05147805) and other lead-in studies, will be given TPIP, once daily (QD), starting with 80 micrograms (μg), up-titrated to highest tolerated dose between 80 μg and 640 μg during 3-week titration period that maybe increased upto maximum dose of 1280 μg QD post initial titration, per investigator's assessment. Overall treatment period=24 months.
Participants transitioning immediately from randomized blinded lead-in TPIP study and who previously received:
1. TPIP- will be given placebo QD(80 μg upto achieved TPIP dose from previous study)along with achieved TPIP dose from previous study in blinded manner during 3-week titration period.
2. Placebo- will be given TPIP QD (80 μg up to achieved placebo dose from previous study)along with achieved placebo dose from previous study in blinded manner during 3-week titration period.Overall treatment period=24 months.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Insmed Incorporated
INDUSTRY
Responsible Party
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Locations
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USA005
Jacksonville, Florida, United States
USA011
Tampa, Florida, United States
USA006
Chicago, Illinois, United States
USA001
Chicago, Illinois, United States
USA102
New York, New York, United States
USA016
Dallas, Texas, United States
ARG009
Quilmes, Buenos Aires, Argentina
ARG006
Rosario, Santa Fe Province, Argentina
ARG007
San Miguel de Tucumán, Tucumán Province, Argentina
ARG004
Córdoba, , Argentina
ARG001
Córdoba, , Argentina
AUT002
Linz, Upper Austria, Austria
AUT001
Vienna, , Austria
BEL003
Brussels, , Belgium
BRA004
Belo Horizonte, Minas Gerais, Brazil
BRA006
Porto Alegre, Rio Grande do Sul, Brazil
BRA002
Blumenau, Santa Catarina, Brazil
DNK001
Aarhus, Central Jutland, Denmark
GER005
Heidelberg, Baden-Wurttemberg, Germany
GER003
München, Bavaria, Germany
GER002
Lübeck, Schleswig-Holstein, Germany
ITA002
Pavia, Lombardy, Italy
ITA005
Monza, , Italy
ITA001
Palermo, , Italy
ITA004
Roma, , Italy
JPN005
Sapporo, Hokkaido, Japan
JPN004
Sapporo, Hokkaido, Japan
JPN007
Kurume-shi, Hukuoka, Japan
JPN006
Tsukuba, Ibaraki, Japan
JPN002
Okayama, Okayama-ken, Japan
JPN003
Suita-Shi, Osaka, Japan
MYS005
Alor Star, Kedah, Malaysia
MYS002
Kuantan, Pahang, Malaysia
MYS004
Sungai Buloh, Selangor, Malaysia
MEX005
Lomas de Guevara, Jalisco, Mexico
MEX001
Monterrey, Nuevo León, Mexico
MEX003
Mexico City, , Mexico
MEX004
San Luis Potosí City, , Mexico
PHL001
Quezon City, National Capital Region, Philippines
PHL002
Makati City, , Philippines
SRB001
Belgrade, , Serbia
SRB003
Belgrade, , Serbia
ESP001
Santander, , Spain
ESP003
Seville, , Spain
GBR001
Bath, Avon, United Kingdom
Countries
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Other Identifiers
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2022-001951-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-505539-11-00
Identifier Type: OTHER
Identifier Source: secondary_id
INS1009-203
Identifier Type: -
Identifier Source: org_study_id