Open-Label Extension Study to evaluate TPIP in participants with PH with ILD
Research type
Research Study
Full 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
IRAS ID
1006618
Contact name
Colin Urquhart
Contact email
Sponsor organisation
Insmed Incorporated
Eudract number
2022-001950-45
Research summary
The purpose of this study is to evaluate the safety and tolerability of the long term use of Treprostinil Palmitil Inhalation Powder (TPIP), an experimental drug, in participants with PH-ILD from Study INS1009-211 and other lead-in studies of TPIP in participants with PH-ILD. Men and women diagnosed with PH-ILD who have participated in previous original clinical studies of TPIP are expected to participate in this study INS1009-212. The study is being conducted at centres in the United Kingdom and in countries around the world. The study will begin with an initial Dose Adjustment period (described later) for 3 weeks (Day 1 to Day 21) after which each participant will receive a single-dose of TPIP every day for the duration of the study. All people in the study will complete the same study procedures. The study will last approximately 24 months starting with the Baseline Visit (Day 1), end of Dose Adjustment period (Week 3), to the end of the Follow Up Visit/Phone Call (Visit 13 or 4 weeks after the last dose of TPIP in Month 24). There will be at least 13 visits at the study clinic, including, if applicable, a Screening Period Visit (Visit 1 occurring up to 30 days before you receive the first dose of the study drug on Day 1), 11 study Treatment Period Visits (Visits 2 through 12/Day 1 through Month 24), and 1 Follow-Up Visit/Phone Call (Visit 13/4 weeks after the last dose of TPIP in Month 24). The Follow-Up Visit may be either at the study clinic or conducted by telephone. Participants will receive up to 24 months of study treatment (13 planned visits), including a 3-week titration.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0003
Date of REC Opinion
10 Jul 2023
REC opinion
Further Information Favourable Opinion