An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Pulmonary Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05649722
• Other study ID #: INS1009-212
• Secondary ID: 2022-001950-4520
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: May 11, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2024
• Source: Insmed Incorporated
• Contact: Insmed Medical Information
• Phone: 1-844-446-7633
• Email: medicalinformation[@]insmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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• Participants who experienced any hypersensitivity or adverse drug reaction or were withdrawn early/discontinued in a previous PH-ILD TPIP study, which in the opinion of the Investigator, could indicate that continued treatment with TPIP may present an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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Hypertension

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Argentina	ARG003	Autonomus City Of Buenos Aires	Buenos Aires
Argentina	ARG001	Rosario	Santa Fe
Australia	AUS005	Macquarie Park	New South Wales
Belgium	BEL002	Liège
Germany	GER002	Berlin
Germany	GER012	Berlin
Germany	GER001	Dresden	Sachsen
Germany	GER003	Essen	Nordrhein-Westfalen
Germany	GER010	Gießen	Hessen
Germany	GER006	Heidelberg	Baden-Württemberg
Germany	GER004	München	Bayern
Italy	ITA004	Milan	Lombardia
Italy	ITA002	Monza	Lombardia
Italy	ITA003	Napoli
Italy	ITA001	Palermo	Sicilia
Spain	ESP005	Barcelona
Spain	ESP010	Barcelona
Spain	ESP007	Oviedo	Asturias
Spain	ESP003	Palma	Islas Baleares
Spain	ESP009	Santiago de Compostela	Galicia
United Kingdom	GBR003	Clydebank	Glasgow
United Kingdom	GBR001	Sheffield	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Insmed Incorporated

Countries where clinical trial is conducted

Argentina,  Australia,  Belgium,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)		Up to approximately 25 months
Secondary	Absolute Change From Pre-Open-Label Extension (OLE) Baseline in 6-Minute Walk Distance (6MWD)		Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Secondary	Relative Change From Pre-OLE Baseline in 6-MWD		Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Secondary	Change From Pre-OLE Baseline in Forced Vital Capacity (FVC)		Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Secondary	Change From Pre-OLE Baseline in Percent Predicted FVC (FVC%)		Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Secondary	Change From Pre-OLE Baseline in Forced Expiratory Volume in 1 Second (FEV1)		Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Secondary	Change From Pre-OLE Baseline in Percent Predicted FEV1 (FEV1%)		Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Secondary	Change From Pre-OLE Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75%)		Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Secondary	Absolute Change From Pre-OLE Baseline in Lung Diffusion Capacity for Carbon Monoxide (DLCO)		Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 12 and 24
Secondary	Relative Change From Pre-OLE Baseline in Lung DLCO		Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 12 and 24
Secondary	Change From Pre-OLE Baseline in the Concentration of N-Terminal Fragment B-Type Natriuretic Peptide (NT-proBNP) in Blood		Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
Secondary	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.	Up to Month 24
Secondary	Annualized Rate of Occurrence of Acute Exacerbations of Underlying Interstitial Lung Disease (AE-ILDs)		Up to Month 24
Secondary	Change From OLE Baseline in the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Score		OLE Baseline (Day 1) to Months 6, 12, 18, and 24
Secondary	Change From OLE Baseline in the Euro Quality of Life-5 Dimension-5 Level (EQ-5D-5L) Questionnaire Score		OLE Baseline (Day 1) to Months 6, 12, 18, and 24
Secondary	Plasma Concentration Levels of Treprostinil Palmitil (TP) and Treprostinil (TRE)		OLE Baseline (Day 1), Months 6, 12, 18, and 24