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

Insmed

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Pulmonary Hypertension; Interstitial Lung Disease

Treatments: Drug: Treprostinil Palmitil Inhalation Powder; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05649722

INS1009-212

2023-505540-19-00 (Other Identifier)

2022-001950-45 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• Participants who experienced any hypersensitivity or adverse drug reaction or were withdrawn early/discontinued in a previous PH-ILD TPIP study, which in the opinion of the Investigator, could indicate that continued treatment with TPIP may present an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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Treprostinil Palmitil Inhalation Powder

Experimental group

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: 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:

Drug: Placebo

Drug: Treprostinil Palmitil Inhalation Powder