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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: 20 Jan 2020

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At a glance

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

    • 20 Jan 2020 According to an Abivax media release, compny announced active U.S. Investigational New Drug (IND) status to extend this trial to US patients. The first U.S. patients are expected to be enrolled in this trial in Q2, 2020.
    • 20 Dec 2019 Planned number of patients changed from 252 to 232.
    • 11 Jun 2019 Status changed from not yet recruiting to recruiting.
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