Back to resultsAn Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term Use of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Primary Purpose
Pulmonary Hypertension, Interstitial Lung Disease
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Treprostinil Palmitil Inhalation Powder
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Treprostinil Palmitil
Eligibility Criteria
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 Exclusion Criteria: Participants who experienced any hypersensitivity or adverse drug reaction or were withdrawn early/discontinued in a previous PH-ILD TPIP study, which in the opinion of the Investigator, could indicate that continued treatment with TPIP may present an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.
Sites / Locations
- BEL002Recruiting
- GER010
- ESP007Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treprostinil Palmitil Inhalation Powder
Arm Description
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: 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. 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.
Outcomes
Primary Outcome Measures
Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)
Secondary Outcome Measures
Absolute Change From Pre-Open-Label Extension (OLE) Baseline in 6-Minute Walk Distance (6MWD)
Relative Change From Pre-OLE Baseline in 6-MWD
Change From Pre-OLE Baseline in Forced Vital Capacity (FVC)
Change From Pre-OLE Baseline in Percent Predicted FVC (FVC%)
Change From Pre-OLE Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Change From Pre-OLE Baseline in Percent Predicted FEV1 (FEV1%)
Change From Pre-OLE Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75%)
Absolute Change From Pre-OLE Baseline in Total Lung Capacity (TLC)
Relative Change From Pre-OLE Baseline in TLC
Absolute Change From Pre-OLE Baseline in Lung Diffusion Capacity for Carbon Monoxide (DLCO)
Relative Change From Pre-OLE Baseline in Lung DLCO
Change From Pre-OLE Baseline in the Concentration of N-Terminal Fragment B-Type Natriuretic Peptide (NT-proBNP) in Blood
Annualized Rate of Clinical Worsening Events Based on Percentage of Participants With Clinical Worsening Events
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.
Annualized Rate of Occurrence of Acute Exacerbations of Underlying Interstitial Lung Disease (AE-ILDs)
Change From OLE Baseline in the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Score
Change From OLE Baseline in the Euro Quality of Life-5 Dimension-5 Level (EQ-5D-5L) Questionnaire Score
Change From OLE Baseline in the Patient Experiences and Satisfaction With Medication (PESaM) Questionnaire Score
Plasma Concentration Levels of Treprostinil Palmitil (TP) and Treprostinil (TRE)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05649722
Brief Title
An Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term Use of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insmed Incorporated
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-211 (NCT05176951) and other lead-in studies of TPIP in participants with PH-ILD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension, Interstitial Lung Disease
Keywords
Treprostinil Palmitil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treprostinil Palmitil Inhalation Powder
Arm Type
Experimental
Arm Description
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:
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.
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.
Intervention Type
Drug
Intervention Name(s)
Treprostinil Palmitil Inhalation Powder
Other Intervention Name(s)
INS1009
Intervention Description
Oral inhalation using a capsule-based dry powder inhaler device.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral placebo inhalation using a capsule-based dry powder inhaler device.
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)
Time Frame
Up to approximately 25 months
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Absolute Change From Pre-OLE Baseline in Total Lung Capacity (TLC)
Time Frame
Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Title
Relative Change From Pre-OLE Baseline in TLC
Time Frame
Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Title
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
Title
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
Title
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
Title
Annualized Rate of Clinical Worsening Events Based on Percentage of Participants With Clinical Worsening Events
Description
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.
Time Frame
Up to Month 24
Title
Annualized Rate of Occurrence of Acute Exacerbations of Underlying Interstitial Lung Disease (AE-ILDs)
Time Frame
Up to Month 24
Title
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
Title
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
Title
Change From OLE Baseline in the Patient Experiences and Satisfaction With Medication (PESaM) Questionnaire Score
Time Frame
OLE Baseline (Day 1) to Months 6, 12, 18, and 24
Title
Plasma Concentration Levels of Treprostinil Palmitil (TP) and Treprostinil (TRE)
Time Frame
OLE Baseline (Day 1), Months 6, 12, 18, and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Insmed Medical Information
Phone
1-844-446-7633
Email
medicalinformation@insmed.com
Facility Information:
Facility Name
BEL002
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
GER010
City
Gießen
State/Province
Hessen
ZIP/Postal Code
35392
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
ESP007
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term Use of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
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