- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05649722
An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term Use of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Insmed Medical Information
- Phone Number: 1-844-446-7633
- Email: medicalinformation@insmed.com
Study Locations
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Buenos Aires
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Autonomus City Of Buenos Aires, Buenos Aires, Argentina, C1280AEB
- Recruiting
- ARG003
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Santa Fe
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Rosario, Santa Fe, Argentina, S2013KDS
- Recruiting
- ARG001
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New South Wales
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Macquarie Park, New South Wales, Australia, 2109
- Recruiting
- AUS005
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Liège, Belgium, 4000
- Recruiting
- BEL002
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Berlin, Germany, 13125
- Recruiting
- GER002
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Berlin, Germany, 14050
- Recruiting
- GER012
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Baden-Württemberg
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Heidelberg, Baden-Württemberg, Germany, 69126
- Recruiting
- GER006
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Bayern
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München, Bayern, Germany, 81377
- Recruiting
- GER004
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Hessen
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Gießen, Hessen, Germany, 35392
- Recruiting
- GER010
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Nordrhein-Westfalen
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Essen, Nordrhein-Westfalen, Germany, 45239
- Recruiting
- GER003
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Sachsen
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Dresden, Sachsen, Germany, 01307
- Recruiting
- GER001
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Napoli, Italy, 80131
- Recruiting
- ITA003
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Lombardia
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Milan, Lombardia, Italy, 20123
- Recruiting
- ITA004
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Monza, Lombardia, Italy, 20900
- Recruiting
- ITA002
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Sicilia
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Palermo, Sicilia, Italy, 90127
- Recruiting
- ITA001
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Barcelona, Spain, 08907
- Recruiting
- ESP005
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Barcelona, Spain, 8035
- Recruiting
- ESP010
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Asturias
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Oviedo, Asturias, Spain, 33011
- Recruiting
- ESP007
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Galicia
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Santiago de Compostela, Galicia, Spain, 15706
- Recruiting
- ESP009
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Islas Baleares
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Palma, Islas Baleares, Spain, 07120
- Recruiting
- ESP003
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Glasgow
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Clydebank, Glasgow, United Kingdom, G81 4DY
- Recruiting
- GBR003
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South Yorkshire
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Sheffield, South Yorkshire, United Kingdom, S10 2JF
- Recruiting
- GBR001
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants who completed the end of treatment visit in Study INS1009-211 (NCT05176951). 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 INS1009-211, 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:
- Participants who experienced any hypersensitivity or adverse drug reaction or were withdrawn early/discontinued in a previous PH-ILD TPIP study, which in the opinion of the Investigator, could indicate that continued treatment with TPIP may present an unreasonable risk for the participant.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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:
The overall treatment period will be 24 months. |
Oral inhalation using a capsule-based dry powder inhaler device.
Other Names:
Oral placebo inhalation using a capsule-based dry powder inhaler device.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)
Time Frame: Up to approximately 25 months
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Up to approximately 25 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Absolute Change From Pre-Open-Label Extension (OLE) Baseline in 6-Minute Walk Distance (6MWD)
Time Frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
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Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
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Relative Change From Pre-OLE Baseline in 6-MWD
Time Frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
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Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
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Change From Pre-OLE Baseline in Forced Vital Capacity (FVC)
Time Frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
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Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
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Change From Pre-OLE Baseline in Percent Predicted FVC (FVC%)
Time Frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
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Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
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Change From Pre-OLE Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
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Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
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Change From Pre-OLE Baseline in Percent Predicted FEV1 (FEV1%)
Time Frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
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Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
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Change From Pre-OLE Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75%)
Time Frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
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Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
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Absolute Change From Pre-OLE Baseline in Lung Diffusion Capacity for Carbon Monoxide (DLCO)
Time Frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 12 and 24
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Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 12 and 24
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Relative Change From Pre-OLE Baseline in Lung DLCO
Time Frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 12 and 24
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Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 12 and 24
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Change From Pre-OLE Baseline in the Concentration of N-Terminal Fragment B-Type Natriuretic Peptide (NT-proBNP) in Blood
Time Frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
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Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
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Annualized Rate of Clinical Worsening Events Based on Percentage of Participants With Clinical Worsening Events
Time Frame: Up to Month 24
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Clinical worsening events are defined as one of the following: Hospitalization due to a cardiopulmonary indication; Lung transplantation; Death from any cause; Decrease in 6MWD ≥ 15% from baseline; Directly related to disease under study, at 2 consecutive visits at least 24 hours apart; Need for additional pulmonary hypertension (PH) therapy.
Annualized clinical worsening event rate is defined as the total number of clinical worsening events that occurred during the treatment period divided by the total number of participant-years during the treatment period.
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Up to Month 24
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Annualized Rate of Occurrence of Acute Exacerbations of Underlying Interstitial Lung Disease (AE-ILDs)
Time Frame: Up to Month 24
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Up to Month 24
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Change From OLE Baseline in the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Score
Time Frame: OLE Baseline (Day 1) to Months 6, 12, 18, and 24
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OLE Baseline (Day 1) to Months 6, 12, 18, and 24
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Change From OLE Baseline in the Euro Quality of Life-5 Dimension-5 Level (EQ-5D-5L) Questionnaire Score
Time Frame: OLE Baseline (Day 1) to Months 6, 12, 18, and 24
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OLE Baseline (Day 1) to Months 6, 12, 18, and 24
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Plasma Concentration Levels of Treprostinil Palmitil (TP) and Treprostinil (TRE)
Time Frame: OLE Baseline (Day 1), Months 6, 12, 18, and 24
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OLE Baseline (Day 1), Months 6, 12, 18, and 24
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INS1009-212
- 2022-001950-45 (EudraCT Number)
- 2023-505540-19-00 (Other Identifier: EU CT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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