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A Phase 1b/2 Study to Demonstrate the Safety and Efficacy of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects with an Ileal Pouch-Anal Anastomosis (PROF). the "PROF" Study

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Trial Profile

A Phase 1b/2 Study to Demonstrate the Safety and Efficacy of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects with an Ileal Pouch-Anal Anastomosis (PROF). the "PROF" Study

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 26 Feb 2025

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At a glance

  • Drugs EXE-346 (Primary)
  • Indications Pouchitis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms PROF
  • Sponsors ExeGi Pharma

Most Recent Events

  • 17 Dec 2024 Planned End Date changed from 1 Jun 2025 to 1 Jun 2026.
  • 17 Dec 2024 Planned primary completion date changed from 1 Jan 2025 to 1 May 2026.
  • 13 Oct 2023 Status changed from not yet recruiting to recruiting.

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