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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00656890 | A Study of MDX-1100 in Subjects With Active Ulcerative Colitis | PHASE2 | COMPLETED | 110 | — | — | Apr 1, 2008 | Sep 1, 2009 | Oct 12, 2015 | 44 | United States, Canada +6 |
| Arm | Type | Description |
|---|---|---|
| 2 | PLACEBO_COMPARATOR | sterile saline for injection |
| 1 | EXPERIMENTAL | MDX-1100 for injection |
| Name | Type | Description |
|---|---|---|
| sterile saline for injection | BIOLOGICAL | 10mg/kg/dose sterile saline injected every other week for a total of 4 doses |
| MDX-1100 | BIOLOGICAL | 10mg/kg/dose MDX-1100 injected every other week for a total of 4 doses |
Inclusion Criteria: * Subjects with active UC on either 5-ASA,corticosteroids,azathioprine(AZA) and or/6-mercaptopurine(6-MP); * Mayo score of 6 to 10 points with moderate to severe disease on endoscopy * Subjects on the following medications; 1. prednisolone ≤ 20 mg daily (or equivalent) (dose ...