Trial of efficacy and safety of NS-229 versus placebo in patients with Eosinophilic Granulomatosis

• Research type

  Research Study

• Full title

  A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of NS-229 in the Treatment of Eosinophilic Granulomatosis With Polyangiitis

• IRAS ID

  1008774

• Contact name

  Oliver flossmann

• Sponsor organisation

  NS Pharma, Inc.

• Eudract number

  2023-504245-32

• Research summary

  This study evaluates the effectiveness of NS-229, a potent JAK1 inhibitor, compared to placebo in patients with eosinophilic granulomatosis with polyangiitis (EGPA). EGPA is an inflammatory vasculitis affecting small- to medium-sized blood vessels, characterized by granuloma formation, asthma, and elevated tissue eosinophilia.
  Participants: A total of 45 subjects from the United States, Canada, Europe, and Japan.
  Treatment Groups: Participants will be randomly assigned to receive either NS-229 or placebo in a 2:1 ratio.
  Duration: The study spans three phases: A screening Period: Up to 4 weeks (minimum 1 week), A treatment Period: 28 weeks and a follow-up Period: 4 weeks.
  Baseline Medication: Patients must have a baseline dose of OGC (prednisolone/prednisone) ranging from ≥7.5 mg/day to ≤60 mg/day.
  Administration: During the treatment period, patients will self-administer 4 tablets of NS-229 or matching placebo daily with water.
  Monitoring: After completing the final dose at Week 28, patients will enter the follow-up period for additional 4 weeks.
  Study Visits: During each study period Participants will have 1 or more visits with your study. The duration of each visit will depend upon the procedures to be performed on a particular visit. Participants will be provided with an electronic device and trained on how to answer questions at home and at the study site. Participants will be required to bring their electronic devices with them at every study visit

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  23/EE/0277

• Date of REC Opinion

  18 Jan 2024

• REC opinion

  Further Information Favourable Opinion