An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
NCT ID: NCT05649722
Last Updated: 2025-12-31
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
31 participants
INTERVENTIONAL
2023-05-11
2026-03-14
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
Participants who are not transitioning immediately from INS1009-211 and other lead-in studies, will be administered TPIP, once daily (QD), during 3-week titration period.
Participants who are transitioning immediately from a randomized blinded lead-in TPIP study and who previously received:
1. TPIP- will be administered placebo QD along with the maximum tolerated dose (MTS) TPIP dose from lead-in study in a blinded manner during 3-week titration period.
2. Placebo- will be administered TPIP QD along with the achieved placebo dose from lead-in study in a blinded manner during 3-week titration period.
The overall treatment period will be 24 months.
Treprostinil Palmitil Inhalation Powder
Oral inhalation using a capsule-based dry powder inhaler device.
Placebo
Oral placebo inhalation using a capsule-based dry powder inhaler device.
Interventions
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Treprostinil Palmitil Inhalation Powder
Oral inhalation using a capsule-based dry powder inhaler device.
Placebo
Oral placebo inhalation using a capsule-based dry powder inhaler device.
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 INS1009-211, or any other lead-in PH-ILD TPIP study.
* Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria
* Initiation of parenteral administration of prostacyclin analogues (eg, TRE, epoprostenol) since the completion of Study INS1009-211 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.
Pregnant or breastfeeding. Male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants of childbearing potential must have a negative urine pregnancy test result at trial entry before the first dose of study drug.
\- Any 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 that may present an unreasonable risk to the study participant as a result of participation in the study.
18 Years
ALL
No
Sponsors
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Insmed Incorporated
INDUSTRY
Responsible Party
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Locations
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ARG003
Autonomus City of Buenos Aires, Buenos Aires, Argentina
ARG001
Rosario, Santa Fe Province, Argentina
AUS005
Macquarie Park, New South Wales, Australia
BEL002
Liège, , Belgium
GER006
Heidelberg, Baden-Wurttemberg, Germany
GER004
München, Bavaria, Germany
GER010
Giessen, Hesse, Germany
GER003
Essen, North Rhine-Westphalia, Germany
GER001
Dresden, Saxony, Germany
GER002
Berlin, , Germany
GER012
Berlin, , Germany
ITA004
Milan, Lombardy, Italy
ITA002
Monza, Lombardy, Italy
ITA001
Palermo, Sicily, Italy
ITA003
Napoli, , Italy
ESP003
Palma, Balearic Islands, Spain
ESP009
Santiago de Compostela, Galicia, Spain
ESP007
Oviedo, Principality of Asturias, Spain
ESP005
Barcelona, , Spain
ESP010
Barcelona, , Spain
GBR003
Clydebank, Glasgow, United Kingdom
GBR001
Sheffield, South Yorkshire, United Kingdom
Countries
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Other Identifiers
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2022-001950-45
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-505540-19-00
Identifier Type: OTHER
Identifier Source: secondary_id
INS1009-212
Identifier Type: -
Identifier Source: org_study_id