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A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis

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A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 29 Jul 2024

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At a glance

  • Drugs Obefazimod (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms ABTECT-2
  • Sponsors Abivax

    • Most Recent Events

    • 26 Jul 2024 Planned End Date changed from 1 Feb 2025 to 1 Apr 2025.
    • 26 Jul 2024 Planned primary completion date changed from 1 Dec 2024 to 1 Mar 2025.
    • 15 Jul 2024 According to an Abivax media release, based on the timelines and by assuming favorable results from the ABTECT trial program , the Company anticipates being in position to submit an NDA to the FDA in late H1 2026, seeking approval of obefazimod for the treatment of moderately to severely active UC.

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