bowel inflammation ulcerative colitis
Conditions
Interventions
See section 4.1- 4.4
treatment with BI655130 or placebo.
bowel inflammation
ulcerative colitis
Sponsors
Boehringer Ingelheim
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - 18 * 60 years at screening and randomisation - Diagnosis of ulcerative colitis *5 months prior to screening - ReceivingTNFi treatment with doses (i.e. dose and dosing interval) unchanged for *4 months prior to randomisation - Mild or moderate disease activity, defined as total Mayo Score (MCS) (*10) - Further criteria apply, refer to protocol section 3.3.2.
Exclusion criteria
Exclusion criteria: - Prior use of more than one different TNF inhibitor or vedolizumab - Extensive colonic resection - Evidence of infection with C. difficile or other intestinal pathogen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| see protocol 5.1.1. Mucosal healing (MCS mESS *1) at Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| See protocol 5.1.2 Clinical remission based on Mayo score (total MCS *2 points, and all subscores *1 point) at Week 8 Histological remission (Robarts (RHI) score *6) at Week 8 Clinical remission based on Mayo score (total MCS *2 points, and all subscores *1 point)at Week 12 Mucosal healing (MCS mESS *1) at Week 12 Histological remission (Robarts (RHI) score *6) at Week 12 Modified clinical remission based on Mayo score (total modified MCS *2 and: RBS =0, Stool Frequency Score (SFS) =0 or 1 and drop *1 from baseline, AND mESS *1) at Week 8 Modified clinical remission based on Mayo score (total modified MCS *2 and: RBS =0,SFS =0 or 1 and drop *1 from baseline, AND mESS *1) at Week 12 | — |
Countries
The Netherlands
Outcome results
None listed