Clinical trial NCT05649722: An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Pulmonary Hypertension
Interstitial Lung Disease
Keywords: Treprostinil Palmitil
Lead sponsor: Insmed Incorporated
Sponsor class: INDUSTRY
First posted: 2022-12-14
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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* Participants who experienced any hypersensitivity or adverse drug reaction or were withdrawn early/discontinued in a previous PH-ILD TPIP study, which in the opinion of the Investigator, could indicate that continued treatment with TPIP may present an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

Primary outcomes:
measure: Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)
timeFrame: Up to approximately 25 months
Secondary outcomes:
measure: Absolute Change From Pre-Open-Label Extension (OLE) Baseline in 6-Minute Walk Distance (6MWD)
timeFrame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
measure: Relative Change From Pre-OLE Baseline in 6-MWD
timeFrame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
measure: Change From Pre-OLE Baseline in Forced Vital Capacity (FVC)
timeFrame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
measure: Change From Pre-OLE Baseline in Percent Predicted FVC (FVC%)
timeFrame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
measure: Change From Pre-OLE Baseline in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
measure: Change From Pre-OLE Baseline in Percent Predicted FEV1 (FEV1%)
timeFrame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
measure: Change From Pre-OLE Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75%)
timeFrame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
measure: Absolute Change From Pre-OLE Baseline in Lung Diffusion Capacity for Carbon Monoxide (DLCO)
timeFrame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 12 and 24
measure: Relative Change From Pre-OLE Baseline in Lung DLCO
timeFrame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 12 and 24
measure: Change From Pre-OLE Baseline in the Concentration of N-Terminal Fragment B-Type Natriuretic Peptide (NT-proBNP) in Blood
timeFrame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24
measure: Annualized Rate of Clinical Worsening Events Based on Percentage of Participants With Clinical Worsening Events
timeFrame: Up to Month 24
measure: Annualized Rate of Occurrence of Acute Exacerbations of Underlying Interstitial Lung Disease (AE-ILDs)
timeFrame: Up to Month 24
measure: Change From OLE Baseline in the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Score
timeFrame: OLE Baseline (Day 1) to Months 6, 12, 18, and 24
measure: Change From OLE Baseline in the Euro Quality of Life-5 Dimension-5 Level (EQ-5D-5L) Questionnaire Score
timeFrame: OLE Baseline (Day 1) to Months 6, 12, 18, and 24
measure: Plasma Concentration Levels of Treprostinil Palmitil (TP) and Treprostinil (TRE)
timeFrame: OLE Baseline (Day 1), Months 6, 12, 18, and 24
Other outcomes:
Locations:
city: Autonomus City Of Buenos Aires
country: Argentina
facility: ARG003
state: Buenos Aires
city: Rosario
country: Argentina
facility: ARG001
state: Santa Fe
city: Macquarie Park
country: Australia
facility: AUS005
state: New South Wales
city: Liège
country: Belgium
facility: BEL002
city: Heidelberg
country: Germany
facility: GER006
state: Baden-Württemberg
city: München
country: Germany
facility: GER004
state: Bayern
city: Gießen
country: Germany
facility: GER010
state: Hessen
city: Essen
country: Germany
facility: GER003
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: GER001
state: Sachsen
city: Berlin
country: Germany
facility: GER002
city: Berlin
country: Germany
facility: GER012
city: Milan
country: Italy
facility: ITA004
state: Lombardia
city: Monza
country: Italy
facility: ITA002
state: Lombardia
city: Palermo
country: Italy
facility: ITA001
state: Sicilia
city: Napoli
country: Italy
facility: ITA003
city: Oviedo
country: Spain
facility: ESP007
state: Asturias
city: Santiago de Compostela
country: Spain
facility: ESP009
state: Galicia
city: Palma
country: Spain
facility: ESP003
state: Islas Baleares
city: Barcelona
country: Spain
facility: ESP005
city: Barcelona
country: Spain
facility: ESP010
city: Clydebank
country: United Kingdom
facility: GBR003
state: Glasgow
city: Sheffield
country: United Kingdom
facility: GBR001
state: South Yorkshire
Study officials:
References: