ulcerative colitits
Conditions
Brief summary
Clinical remission as measured by the modified Mayo score (mMS; defined as mMS of 0 to 2, including stool frequency subscore [SFS] of 0 or 1, rectal bleeding subscore [RBS] of 0, and centrally-read endoscopy subscore [ESS] of 0 or 1) at Week 12
Detailed description
Endoscopic remission (defined as centrally-read ESS of 0) at Week 12, Clinical response (defined as a decrease from baseline in mMS ≥2 and at least a 30% reduction from baseline, and a decrease in RBS of ≥1 or an absolute RBS of 0 or 1) at Week 12, Endoscopic improvement (defined as centrally-read ESS of 0 or 1) at Week 12, mMS change from baseline at Week 12, SFS of 0 or 1 at Week 12, RBS of 0 at Week 12, Occurrence of treatment-emergent adverse events (AEs) up to Week 12 and up to Week 104
Interventions
DRUGBI 3032950
Sponsors
Boehringer Ingelheim International GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission as measured by the modified Mayo score (mMS; defined as mMS of 0 to 2, including stool frequency subscore [SFS] of 0 or 1, rectal bleeding subscore [RBS] of 0, and centrally-read endoscopy subscore [ESS] of 0 or 1) at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Endoscopic remission (defined as centrally-read ESS of 0) at Week 12, Clinical response (defined as a decrease from baseline in mMS ≥2 and at least a 30% reduction from baseline, and a decrease in RBS of ≥1 or an absolute RBS of 0 or 1) at Week 12, Endoscopic improvement (defined as centrally-read ESS of 0 or 1) at Week 12, mMS change from baseline at Week 12, SFS of 0 or 1 at Week 12, RBS of 0 at Week 12, Occurrence of treatment-emergent adverse events (AEs) up to Week 12 and up to Week 104 | — |
Countries
Belgium, Czechia, Poland, Slovakia
Outcome results
None listed