Efficacy and Safety of Seralutinib in Adult Subjects with PH‑ILD

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) Followed by a Long-Term Extension Evaluating Safety and Efficacy (SERANATA)

• IRAS ID

  1013061

• Contact name

  Conor O'Donovan

• Contact email

  regaffairs@gossamerbio.com

• Sponsor organisation

  GB002, Inc.

• Clinicaltrials.gov Identifier

  NCT07181382

• Research summary

  This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral inhalation of seralutinib in patients with Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD). PH-ILD is a progressive, ultimately fatal disease that affects the daily activity and quality of life of patients. The purpose of this study is to compare the effects of seralutinib to placebo (an inactive substance that looks like seralutinib, given the same way but has no effect on the body) on the ability to exercise when it is given to PH-ILD patients who are already taking other medications. Seralutinib was formulated to be inhaled so that it is delivered right where it is needed. This also means the amount of medication in the body is reduced. This study includes 6 week screening period, a 24 week treatment period and long term extension period of up to 144 weeks.
  The study treatment is a powder that is inhaled with a dry powder inhaler device, taken twice daily.
  During the study patients are asked to complete questionnaires relating to quality of life, their PH-ILD symptoms and their experience taking the study medication.
  Approximately 480 participants will be randomly assigned in a 1:1:1 ratio to either seralutinib 90mg, seralutinib 120mg or placebo.
  The study involves procedures including physical examinations, vital signs, ECG, Six Minute Walk Test (6MWT) , pulmonary function test and during screening, if required, a chest CT-scan maybe performed, as well as an echocardiogram. There are a number of sub-studies which would require participants to undertake additional procedures such as Right heart catheterization.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  26/NW/0028

• Date of REC Opinion

  15 Apr 2026

• REC opinion

  Further Information Unfavourable Opinion