Last updated on January 2020

BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis

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 date of signing informed consent, males or females
  • Diagnosis of ulcerative colitis 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report
  • Moderate to severe activity (total MCS 6 to 12 with a RBS 1 AND an SFS 1 AND mESS 2 within 7-28 days prior to first dose)
  • Endoscopic activity extending proximal to the rectum ( 15 cm from anal verge)
  • Well-documented demonstration of inadequate response or loss of response or have had unacceptable side effects with approved doses of TNF antagonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past (screening of both TNF antagonists-AND-Vedolizumab failure patients will be capped once 48 randomized patients in Part 1 and 117 randomized patients in Part 2 meet this criterion; patients who have already been screened at the time of the cap will continue to be randomized into the study)
  • Further inclusion criteria apply

Exclusion Criteria:

  • Evidence of abdominal abscess at screening
  • Evidence of fulminant colitis or toxic megacolon at screening
  • Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
  • Further exclusion criteria apply

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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