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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01466374 | Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease | PHASE2 | COMPLETED | 121 | — | — | Dec 1, 2011 | Dec 1, 2014 | Oct 12, 2015 | 33 | United States, Belgium +6 |
CDAI: Crohn's Disease Activity Index
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Induction | EXPERIMENTAL | Placebo |
| Cohort 2: Induction | EXPERIMENTAL | Anti-IP-10 Antibody |
| Cohort 3: Induction | EXPERIMENTAL | Anti-IP-10 Antibody |
| Cohort 1: Maintenance | EXPERIMENTAL | Placebo |
| Cohort 2: Maintenance | EXPERIMENTAL | Anti-IP-10 Antibody |
| Cohort 3: Maintenance | EXPERIMENTAL | Anti-IP-10 Antibody |
| Cohort 1: Open Label | EXPERIMENTAL | Anti-IP-10 Antibody |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Normal Saline, Intravenous (IV), 0 mg, Once a week for the first week and every other week thereafter, 11 weeks |
| BMS-936557 (Anti-IP-10 Antibody) | DRUG | Solution for IV administration, Intravenous, 10 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks |
Inclusion Criteria: * Adults subjects with confirmed Crohn's Disease (CD) for at least 3 months * Moderate to severely active CD as defined by Crohn's Disease Activity Index (CDAI) 220 to 450 * In the past have had insufficient response and or intolerance to ≥ 1 of the conventional therapy (immunos...