Ulcerative Colitis
Conditions
Brief summary
Achievement of endoscopic improvement at Week 48, defined as a centrally read endoscopy subscore of 0 or 1 (score of 1 modified to exclude friability): superiority of risankizumab vs. vedolizumab.
Detailed description
The achievement of clinical remission per mMS at Week 48, defined as SFS ≤ 1 and not greater than Baseline, RBS = 0, and a centrally read endoscopy subscore of 0 or 1 (score of 1 modified to exclude friability): non-inferiority of risankizumab vs. vedolizumab test first followed by superiority test.
Interventions
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of endoscopic improvement at Week 48, defined as a centrally read endoscopy subscore of 0 or 1 (score of 1 modified to exclude friability): superiority of risankizumab vs. vedolizumab. | — |
Secondary
| Measure | Time frame |
|---|---|
| The achievement of clinical remission per mMS at Week 48, defined as SFS ≤ 1 and not greater than Baseline, RBS = 0, and a centrally read endoscopy subscore of 0 or 1 (score of 1 modified to exclude friability): non-inferiority of risankizumab vs. vedolizumab test first followed by superiority test. | — |
Countries
Austria, Bulgaria, Croatia, Czechia, Estonia, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, Sweden
Outcome results
None listed