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Double-blind, Randomized, Non-inferiority Phase III Trial on the Efficacy and Tolerability of 2 mg Once Daily vs. 1 mg Twice Daily Budesonide Orodispersible Tablets in Adults With Eosinophilic Esophagitis

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Trial Profile

Double-blind, Randomized, Non-inferiority Phase III Trial on the Efficacy and Tolerability of 2 mg Once Daily vs. 1 mg Twice Daily Budesonide Orodispersible Tablets in Adults With Eosinophilic Esophagitis

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Aug 2025

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At a glance

  • Drugs Budesonide (Primary)
  • Indications Eosinophilic oesophagitis
  • Focus Registrational; Therapeutic Use
  • Acronyms EOS-4
  • Sponsors Dr Falk Pharma

Most Recent Events

  • 25 Jul 2025 Planned End Date changed from 1 Sep 2025 to 1 Jun 2026.
  • 25 Jul 2025 Planned primary completion date changed from 1 Aug 2025 to 1 Mar 2026.
  • 19 Sep 2024 Planned number of patients changed from 242 to 308.

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