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A Phase 2b, Open-label, Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis

Trial Profile

A Phase 2b, Open-label, Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 May 2025

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At a glance

  • Drugs Obefazimod (Primary)
  • Indications Ulcerative colitis
  • Focus Therapeutic Use
  • Sponsors Abivax

Most Recent Events

  • 27 Apr 2025 Status changed from active, no longer recruiting to completed.
  • 23 Jan 2025 According to an Abivax media release, company today announced that scientific abstracts including data from this trial, will be presented at The European Crohn's and Colitis Organization's (ECCO's) 20th Annual Congress as part of scientific exchange, taking place Feb 19-22, 2025, in Berlin, Germany.
  • 15 Jul 2024 According to an Abivax media release, in an interim analysis as of July 31, 2023, of the 71 eligible patients, 63 completed their 48-week visit, 84% (53 of 63 patients) achieved disease control defined as stable or improved Modified Mayo Score on 25mg once-daily obefazimod. No new safety signals were detected in UC patients treated up to five years with oral, once daily obefazimod.

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