Phase 3 Study of Treprostinil Powder in PH-ILD: Safety and efficacy

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease

• IRAS ID

  1013123

• Contact name

  Urnell Greaves

• Contact email

  Urnell.Greaves@insmed.com

• Sponsor organisation

  Insmed Incorporated

• Clinicaltrials.gov Identifier

  NCT07179380

• Research summary

  This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of TPIP in participants diagnosed with PH-ILD. Approximately 344 participants (males and females above 18 years of age) will be randomly assigned 1:1 to receive TPIP or matching placebo for 24 weeks; stratifiby geographic region (Europe, Japan, North America and Rest of the World), ILD subtype (IIP, CPFE, CTD-ILD, Other), and baseline 6MWD (≤ 250 m and > 250 m).
  Approximately 50 participants in the selected sites will be included in a haemodynamic substudy that would include an additional RHC assessment at the end of treatment.
  Including the Screening Period of up to 30 days, the Treatment Period of 24 weeks, and a 4-week Follow-Up Period for participants not rolling over to the OLE, the total duration of study participation for each participant will be up to 32 weeks. For an individual participant, the treatment duration will be 24 weeks.
  The study treatments will be supplied by the Sponsor in HDPE bottles. Administration of the study drug will be by oral inhalation using a dry powder inhaler device, once daily. Training on the inhalation technique will be performed during Screening or at the Baseline visit prior to the first dose of study drug. The indicated dose will be achieved with a combination of 1 to 3 dry powder capsules containing 80 µg, 160 µg, 320 µg, or 640 µg of TPIP/placebo.
  Participants will be maintaining a daily dosing diary, will be instructed to immediately inform the site of any adverse events, and to only change the dose if directed by the Investigator/delegate.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  25/LO/0908

• Date of REC Opinion

  5 Feb 2026

• REC opinion

  Further Information Favourable Opinion