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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03860896 | GB004 in Adult Subjects With Active Ulcerative Colitis | PHASE1 | COMPLETED | 34 | — | — | Apr 24, 2019 | Dec 17, 2019 | Jan 14, 2020 | 3 | United States, Georgia +1 |
To evaluate the safety and tolerability of GB004 for 56 days in terms of incidence of treatment emergent adverse events reported.
| Arm | Type | Description |
|---|---|---|
| GB004 | EXPERIMENTAL | GB004 for oral administration daily |
| Placebo | PLACEBO_COMPARATOR | Placebo for oral administration daily |
| Name | Type | Description |
|---|---|---|
| GB004 | DRUG | GB0004 high dose |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Patients aged 18-74, receiving therapy for active ulcerative colitis confirmed by Mayo Score assessment, and evidence of colonic inflammation. Exclusion Criteria: * Evidence of Crohn's disease, indeterminate colitis, or presence of bacterial or parasitic infection. * Patient...