Crohn's disease
Conditions
Brief summary
Participant incidence of TEAEs, SAEs, and AEs leading to discontinuation throughout study
Detailed description
Proportion of participants achieving endoscopic response defined as a decrease in SES-CD ≥50% from the Baseline at W14, assessed by central read, Proportion of participants achieving clinical remission (CDAI <150) at W14, Proportion of participants achieving clinical remission by PRO2 (average daily very soft or liquid SF ≤2.8 and AP score ≤1, and not worse than the Baseline) at W14, PK parameters of RO7790121 (e.g., Ctrough)
Interventions
DRUGRVT-3101
DRUGRO7790121
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant incidence of TEAEs, SAEs, and AEs leading to discontinuation throughout study | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving endoscopic response defined as a decrease in SES-CD ≥50% from the Baseline at W14, assessed by central read, Proportion of participants achieving clinical remission (CDAI <150) at W14, Proportion of participants achieving clinical remission by PRO2 (average daily very soft or liquid SF ≤2.8 and AP score ≤1, and not worse than the Baseline) at W14, PK parameters of RO7790121 (e.g., Ctrough) | — |
Countries
Belgium, Bulgaria, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Slovakia, Spain
Outcome results
None listed