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

NCT05649722 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: INS1009-2122022-001950-452023-505540-19-00
• Study Type: interventional
• Target: 31
• Locations: 7 countries
• Sites: 22

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.

Conditions

Pulmonary Hypertension; Interstitial Lung Disease

Keywords

Treprostinil Palmitil

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)

  Up to approximately 25 months

Secondary Outcomes (15)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Treprostinil Palmitil Inhalation Powder

EXPERIMENTAL

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.

Drug: Treprostinil Palmitil Inhalation Powder; Drug: Placebo

Interventions

Treprostinil Palmitil Inhalation Powder DRUG

Oral inhalation using a capsule-based dry powder inhaler device.

Also known as: INS1009

Treprostinil Palmitil Inhalation Powder

Placebo DRUG

Oral placebo inhalation using a capsule-based dry powder inhaler device.

Treprostinil Palmitil Inhalation Powder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insmed Incorporated: lead

Study Sites (22)

ARG003

Autonomus City of Buenos Aires, Buenos Aires, C1280AEB, Argentina

Location

ARG001

Rosario, Santa Fe Province, S2013KDS, Argentina

Location

AUS005

Macquarie Park, New South Wales, 2109, Australia

Location

BEL002

Liège, 4000, Belgium

Location

GER006

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

GER004

München, Bavaria, 81377, Germany

Location

GER010

Giessen, Hesse, 35392, Germany

Location

GER003

Essen, North Rhine-Westphalia, 45239, Germany

Location

GER001

Dresden, Saxony, 01307, Germany

Location

GER002

Berlin, 13125, Germany

Location

GER012

Berlin, 14050, Germany

Location

ITA004

Milan, Lombardy, 20123, Italy

Location

ITA002

Monza, Lombardy, 20900, Italy

Location

ITA001

Palermo, Sicily, 90127, Italy

Location

ITA003

Naples, 80131, Italy

Location

ESP003

Palma, Balearic Islands, 07120, Spain

Location

ESP009

Santiago de Compostela, Galicia, 15706, Spain

Location

ESP007

Oviedo, Principality of Asturias, 33011, Spain

Location

ESP005

Barcelona, 08907, Spain

Location

ESP010

Barcelona, 8035, Spain

Location

GBR003

Clydebank, Glasgow, G81 4DY, United Kingdom

Location

GBR001

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: May 11, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5); GB (2); DE (7); IT (4); AU (1); AR (2); BE (1)