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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05649722




Registration number
NCT05649722
Ethics application status
Date submitted
6/12/2022
Date registered
14/12/2022

Titles & IDs
Public title
An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Scientific title
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
Secondary ID [1] 0 0
2022-001950-45
Secondary ID [2] 0 0
INS1009-212
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension 0 0
Interstitial Lung Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Treprostinil Palmitil Inhalation Powder
Treatment: Drugs - Placebo

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:

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.


Treatment: Drugs: Treprostinil Palmitil Inhalation Powder
Oral inhalation using a capsule-based dry powder inhaler device.

Treatment: Drugs: Placebo
Oral placebo inhalation using a capsule-based dry powder inhaler device.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)
Timepoint [1] 0 0
Up to approximately 25 months
Secondary outcome [1] 0 0
Absolute Change From Pre-Open-Label Extension (OLE) Baseline in 6-Minute Walk Distance (6MWD)
Timepoint [1] 0 0
Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Secondary outcome [2] 0 0
Relative Change From Pre-OLE Baseline in 6-MWD
Timepoint [2] 0 0
Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Secondary outcome [3] 0 0
Change From Pre-OLE Baseline in Forced Vital Capacity (FVC)
Timepoint [3] 0 0
Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Secondary outcome [4] 0 0
Change From Pre-OLE Baseline in Percent Predicted FVC (FVC%)
Timepoint [4] 0 0
Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Secondary outcome [5] 0 0
Change From Pre-OLE Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Timepoint [5] 0 0
Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Secondary outcome [6] 0 0
Change From Pre-OLE Baseline in Percent Predicted FEV1 (FEV1%)
Timepoint [6] 0 0
Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Secondary outcome [7] 0 0
Change From Pre-OLE Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75%)
Timepoint [7] 0 0
Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Secondary outcome [8] 0 0
Absolute Change From Pre-OLE Baseline in Lung Diffusion Capacity for Carbon Monoxide (DLCO)
Timepoint [8] 0 0
Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 12 and 24
Secondary outcome [9] 0 0
Relative Change From Pre-OLE Baseline in Lung DLCO
Timepoint [9] 0 0
Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 12 and 24
Secondary outcome [10] 0 0
Change From Pre-OLE Baseline in the Concentration of N-Terminal Fragment B-Type Natriuretic Peptide (NT-proBNP) in Blood
Timepoint [10] 0 0
Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Secondary outcome [11] 0 0
Annualized Rate of Clinical Worsening Events Based on Percentage of Participants With Clinical Worsening Events
Timepoint [11] 0 0
Up to Month 24
Secondary outcome [12] 0 0
Annualized Rate of Occurrence of Acute Exacerbations of Underlying Interstitial Lung Disease (AE-ILDs)
Timepoint [12] 0 0
Up to Month 24
Secondary outcome [13] 0 0
Change From OLE Baseline in the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Score
Timepoint [13] 0 0
OLE Baseline (Day 1) to Months 6, 12, 18, and 24
Secondary outcome [14] 0 0
Change From OLE Baseline in the Euro Quality of Life-5 Dimension-5 Level (EQ-5D-5L) Questionnaire Score
Timepoint [14] 0 0
OLE Baseline (Day 1) to Months 6, 12, 18, and 24
Secondary outcome [15] 0 0
Plasma Concentration Levels of Treprostinil Palmitil (TP) and Treprostinil (TRE)
Timepoint [15] 0 0
OLE Baseline (Day 1), Months 6, 12, 18, and 24

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/03/2026
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
AUS005 - Macquarie Park
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Santa Fe
Country [3] 0 0
Belgium
State/province [3] 0 0
Liège
Country [4] 0 0
Germany
State/province [4] 0 0
Baden-Württemberg
Country [5] 0 0
Germany
State/province [5] 0 0
Bayern
Country [6] 0 0
Germany
State/province [6] 0 0
Hessen
Country [7] 0 0
Germany
State/province [7] 0 0
Nordrhein-Westfalen
Country [8] 0 0
Germany
State/province [8] 0 0
Sachsen
Country [9] 0 0
Germany
State/province [9] 0 0
Berlin
Country [10] 0 0
Italy
State/province [10] 0 0
Lombardia
Country [11] 0 0
Italy
State/province [11] 0 0
Sicilia
Country [12] 0 0
Italy
State/province [12] 0 0
Napoli
Country [13] 0 0
Spain
State/province [13] 0 0
Asturias
Country [14] 0 0
Spain
State/province [14] 0 0
Galicia
Country [15] 0 0
Spain
State/province [15] 0 0
Islas Baleares
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Glasgow
Country [18] 0 0
United Kingdom
State/province [18] 0 0
South Yorkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Insmed Incorporated
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Insmed Medical Information
Address 0 0
Country 0 0
Phone 0 0
1-844-446-7633
Fax 0 0
Email 0 0
medicalinformation@insmed.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05649722