EU Clinical Trial 2018-003558-26

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.  May 23, 2019

Main objective of the trial: The primary objective of the study is to determine an optimal ABX464 dose to be used in moderate to severe active ulcerative colitis patients who have failed or are intolerant to immunomodulators, Anti-TNFα, vedolizumab, JAK inhibitors and/or corticosteroids by comparing the mean change from baseline in the MMS at week 8 between each ABX464 group and placebo.

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AT BE BY CA CZ DE FR HU IT LT NL PL RS SI SK UA
Keywords
ABX464 Acute ulcerative colitis

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Source:  EMA Last updated:  May 30, 2019

From ClinicalTrialsRegister.eu, a database of the European Medicines Agency. This record may not reflect the most current and accurate data available from the EMA.