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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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Trial Profile

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

Latest Information Update: 06 May 2025

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At a glance

  • Drugs Obefazimod (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms ABTECT-1
  • Sponsors Abivax

Most Recent Events

  • 29 Apr 2025 According to an Abivax media release, top-line results from the 8-week induction trials anticipated in Q3 2025, with 44-week maintenance data on track for Q2 2026 and, if successful, NDA submission planned for H2 2026.Blinded baseline characteristics align with pre-specified target population and are consistent with Phase 2b UC trial participant characteristics. Cash runway through ABTECT induction trials readout and into Q4 2025.
  • 29 Apr 2025 Status changed from recruiting to active, no longer recruiting, according to an Abivax media release.
  • 09 Jan 2025 According to an Abivax media release, top-line results from the ABTECT induction trial expected in Q3 2025.

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