BI 655130 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 agonists (infliximab,
adalimumab, golimumab) and/or vedolizumab in the past

- 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