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

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 TNFɑ antagonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past (screening of both TNFɑ 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