Ulcerative Colitis (UC)
Conditions
Brief summary
Treatment-emergent adverse events
Detailed description
Clinical response at week 52 and 104, Clinical remission at week 52 and 104, Durable clinical remission at week 52 and 104, Endoscopic remission at week 52 and 104, Histologic remission at week 52 and 104, Corticosteroid-free remission at week 52 and 104 in subjects receiving corticosteroids at randomization of the phase 2 parent study (Study 20170104), Combined endoscopic and histologic remission at week 52 and 104, Symptomatic remission at week 52 and 104, Change from baseline of Study 20170104 in histological score (Geboes) at week 52 and 104
Interventions
None listed
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment-emergent adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response at week 52 and 104, Clinical remission at week 52 and 104, Durable clinical remission at week 52 and 104, Endoscopic remission at week 52 and 104, Histologic remission at week 52 and 104, Corticosteroid-free remission at week 52 and 104 in subjects receiving corticosteroids at randomization of the phase 2 parent study (Study 20170104), Combined endoscopic and histologic remission at week 52 and 104, Symptomatic remission at week 52 and 104, Change from baseline of Study 20170104 in histological score (Geboes) at week 52 and 104 | — |
Countries
Austria, Belgium, Bulgaria, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Netherlands, Poland, Romania, Slovakia, Spain
Outcome results
None listed