Last updated on January 2020

A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ulcerative Colitis
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

Inclusion Criteria

  • 18 - 75 years at screening and randomisation
  • Diagnosis of ulcerative colitis >= 5 months prior to screening
  • Receiving TNFi treatment with doses (i.e. dose and dosing interval) unchanged for >= 4 months (Infliximab) or >= 2 Monaten (Adalimumab or Golimumab) prior to randomisation
  • Mild or moderate disease activity, defined as total Mayo Score (MCS) (<= 10)
  • Further inclusion criteria apply

Exclusion Criteria:

  • Prior use of more than two different TNF inhibitors or vedolizumab
  • Extensive colonic resection
  • Evidence of infection with C. difficile or other intestinal pathogen <28 days prior to screening
  • Active or latent tuberculosis
  • Further exclusion criteria apply

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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