BI 655130 Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:4/6/2019
Start Date:March 27, 2018
End Date:May 30, 2021
Contact:Boehringer Ingelheim
Email:clintriage.rdg@boehringer-ingelheim.com
Phone:1-800-243-0127

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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.


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
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