A study to evaluate the effects of Treprostinil Palmitil Inhalation Powder in participants with PAH

• Research type

  Research Study

• Full title

  A Phase 2b, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to valuate the Efficacy, Safety, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in participants with Pulmonary Arterial Hypertension

• IRAS ID

  1005143

• Contact name

  Colin Urquhart

• Contact email

  colin.urquhart@insmed.com

• Sponsor organisation

  Insmed Incorporated

• Eudract number

  2021-001528-16

• Clinicaltrials.gov Identifier

  NCT05147805

• Research summary

  The purpose of this study is to evaluate treprostinil palmitil inhalation powder (TPIP), an experimental drug being tested for treatment of Pulmonary Arterial Hypertension PAH). Experimental” means that the study drug is currently being tested in clinical research studies and has not been approved by the Medicines and Healthcare products Regulatory Agency (MHRA). The study aims to learn if TPIP helps PAH to get better (or makes it worse), and to find out if TPIP is well tolerated (has few side effects). Another aim is to learn more about TPIP and how it works in the human body.
  Approximately 99 men and women from the ages of 18 to 75 years (from 20 to 75 years in Japan) with diagnosed PAH are expected to participate in Study INS1009-202. The study is being conducted at clinics in the United Kingdom and in countries around the world.
  Participants will be randomly assigned to receive either study drug or placebo. This is a double-blind study, meaning that neither participants, the study doctor, nor the study staff will know what study drug (TPIP or placebo) participants have received until the study is completed.
  All people in the study will complete the same study procedures. The study will last approximately 24 weeks from the Screening Visit (Visit 1) to the end of the Follow Up Visit/Phone Call (Visit 8/Day 140). There will be at least 8 visits at the study clinic (possibly more, depending on the number of visits required for Screening), including at least 2 Screening Period Visits (occurring up to 30 days before participants receive the first dose of study drug), 6 Treatment Period Visits (Visits 2 through 7/Days 1 through 112), and 1 Follow-Up Visit/Phone Call (Visit 8/Day 140).

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  22/SC/0153

• Date of REC Opinion

  6 Jul 2022

• REC opinion

  Further Information Favourable Opinion