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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

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: Recruiting
Phase of Trial: Phase II

Latest Information Update: 05 Dec 2019

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At a glance

  • Drugs ABX 464 (Primary)
  • Indications Ulcerative colitis
  • Focus Therapeutic Use
  • Sponsors Abivax
  • Most Recent Events

    • 11 Jun 2019 Status changed from not yet recruiting to recruiting.
    • 30 Apr 2019 According to an Abivax media release, The study, which is to be conducted in up to 150 sites in more than 15 countries, will be run under the leadership of its steering committee (Prof. Severine Vermeire, M.D., Ph.D., Prof. Herbert Tilg, M.D. Ph.D., Prof. Xavier Hebuterne, M.D., Ph.D., and Prof. William Sandborn, M.D.).
    • 30 Apr 2019 According to an Abivax media release, this study is expected to confirm the findings from the Phase 2a trial, as well as determine the optimal dose for Phase 3 pivotal studies.
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