A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in Patients With Moderate-to-severely Active Ulcerative Colitis Who Have Failed Previous Biologics Therapy

This trial has two sequentially enrolling parts with different objectives. The primary
objectives of this trial are

- to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with
moderate-to-severely active ulcerative colitis who have failed previous biologic
treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II)

- to confirm efficacy and safety of BI655130 (SPESOLIMAB) in patients with
moderate-to-severely active ulcerative colitis who have failed previous biologic
treatments in Part 2 (Phase III)

- To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the
target population to be evaluated in study 1368-0020.