BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
Status:
Completed
Trial end date:
2020-05-18
Target enrollment:
Participant gender:
Summary
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.