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

Phase 2

Recruiting

• Conditions: Pulmonary Hypertension; Interstitial Lung Disease

• Registration Number: NCT05649722
• Lead Sponsor: Insmed Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-6
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Inclusion Criteria:<br><br> - Participants who completed the end of treatment visit in Study INS1009-211<br> (NCT05176951). Participants for whom the OLE study was not available at the time of<br> their completion of the lead-in study are eligible for enrolment within one year of<br> their lead-in end of treatment visit.<br><br> - Complete baseline screening assessments to confirm eligibility to participate if<br> more than 30 days have elapsed since the end of the study visit in Study<br> INS1009-211, or any other lead-in PH-ILD TPIP study.<br><br> - Capable of giving signed informed consent that includes compliance with the<br> requirements and restrictions listed in the informed consent form (ICF) and in this<br> protocol.<br><br>Exclusion Criteria:<br><br> - Participants who experienced any hypersensitivity or adverse drug reaction or were<br> withdrawn early/discontinued in a previous PH-ILD TPIP study, which in the opinion<br> of the Investigator, could indicate that continued treatment with TPIP may present<br> an unreasonable risk for the participant.<br><br> - Initiation of parenteral administration of prostacyclin analogues (eg, TRE,<br> epoprostenol) since the completion of Study INS1009-211 or other TPIP studies.<br> Initiation of inhaled prostacyclin analogues (eg, TRE [Tyvaso] or iloprost) and oral<br> prostacyclin analogues (eg, TRE [Orenitram]) or receptor agonists (eg, selexipag)<br> are permitted if stopped 24 hours prior to the start of study drug administration.<br><br>Pregnant or breastfeeding. Male and female participants must use contraceptives that are<br>consistent with local regulations regarding the methods of contraception for those<br>participating in clinical studies. Female participants of childbearing potential must<br>have a negative urine pregnancy test result at trial entry before the first dose of study<br>drug.<br><br> - Any medical or psychological condition, including relevant laboratory abnormalities<br> at screening that, in the opinion of the Investigator, suggest a new and/or<br> insufficiently understood disease that may present an unreasonable risk to the study<br> participant as a result of participation in the study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)