Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03775109 | IL-1 Signal Inhibition in Alcoholic Hepatitis | PHASE2 | COMPLETED | 55 | — | — | Feb 12, 2019 | Mar 31, 2023 | Mar 11, 2025 | 16 | United Kingdom |
Histological improvement is defined as a reduction in lobular inflammation (regardless of cell type).
| Arm | Type | Description |
|---|---|---|
| Canakinumab 150mg/ml solution for injection | ACTIVE_COMPARATOR | 150mg/ml solution for injection |
| Dextrose | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Canakinumab 150mg/ml solution for injection | DRUG | Canakinumab 150mg/ml solution for injection |
| Placebo | DRUG | 100ml 5% Dextrose |
Inclusion Criteria: * Male and female patients aged 18 years or older at screening * Clinical diagnosis of alcoholic hepatitis at screening: * Serum bilirubin \> 80μmol/L * History of excess alcohol (\> 80g/day male, \> 60g/day female) to within 6 weeks before screening visit * Less than 4 w...