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A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose, Induction Study to Evaluate the Safety, Tolerability and Optimal Dose of ABX464 Compared With Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Have Inadequate Response, Loss of Response, or Intolerance With at Least One of the Following Agents: Immunosuppressant Treatment (i.e. Azathioprine, 6-mercaptopurine, Methotrexate), Tumor Necrosis Factor Alpha [TNF-α] Inhibitors, Vedolizumab, JAK Inhibitors and/or Corticosteroid Treatment

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Trial Profile

A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose, Induction Study to Evaluate the Safety, Tolerability and Optimal Dose of ABX464 Compared With Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Have Inadequate Response, Loss of Response, or Intolerance With at Least One of the Following Agents: Immunosuppressant Treatment (i.e. Azathioprine, 6-mercaptopurine, Methotrexate), Tumor Necrosis Factor Alpha [TNF-α] Inhibitors, Vedolizumab, JAK Inhibitors and/or Corticosteroid Treatment

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 16 Feb 2024

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At a glance

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

    • Most Recent Events

    • 13 Feb 2024 According to an Abivax media release, data from this study will be presented at the 19th Congress of the European Crohn's and Colitis Organisation (ECCO) on February 21-24, 2024, in Stockholm, Sweden.
    • 17 Oct 2023 Results assessing long-term effects of obefazimod on miR-124 in blood and rectal biopsies of patients enrolled in a 96-week maintenance study, presented at the 31st United European Gastroenterology Week.
    • 17 Oct 2023 Results (n=205) assessing Correlation of Mir-124 Upregulation and Pk Parameters in Blood of Patients with Moderate-to-Severe Ulcerative Colitis Receiving Obefazimod for 16 Weeks presented at the 31st United European Gastroenterology Week
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