A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 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 BI 655130 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 BI 655130 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.
18 Years to 75 Years
Accepting Healthy Volunteers?
- 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
- 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