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A Phase 3, Double-Blind, Randomized, Two-Phase, Active-Controlled Study to Evaluate the Efficacy and Safety of BLI5100 in Patients with Erosive Esophagitis

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Trial Profile

A Phase 3, Double-Blind, Randomized, Two-Phase, Active-Controlled Study to Evaluate the Efficacy and Safety of BLI5100 in Patients with Erosive Esophagitis

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 12 May 2025

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At a glance

  • Drugs Tegoprazan (Primary) ; Lansoprazole; Proton pump inhibitors
  • Indications Erosive oesophagitis
  • Focus Registrational; Therapeutic Use
  • Acronyms triumph program; TRIUMpH-EE
  • Sponsors Braintree Laboratories

Most Recent Events

  • 23 Apr 2025 According to Sebela Pharmaceuticals media release, Braintree intends to submit results from the TRIUMpH Phase 3 studies to a high impact, peer reviewed journal along with presentation of this data at a leading gastroenterology conference in the future.
  • 23 Apr 2025 According to Sebela Pharmaceuticals media release, the maintenance phase of this study will complete in Q3 2025 with a New Drug Application inclusive of both the EE and NERD indications planned for filing with FDA in Q4 2025.
  • 23 Apr 2025 According to Sebela Pharmaceuticals media release, primary endpoint (Healing Phase: Percentage of patients with complete healing by Week 8.) has been met.

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