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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01764594 | Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus | PHASE1 | COMPLETED | 24 | — | — | Jan 1, 2013 | Aug 1, 2014 | Jul 16, 2015 | 21 | Belgium, Bulgaria +5 |
| Arm | Type | Description |
|---|---|---|
| CDP7657 | EXPERIMENTAL | CDP7657 100 mg/ ml solution 30 mg/ kg initial dose 15 mg/ kg every other week 10 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| CDP7657 | BIOLOGICAL | CDP7657 100 mg/ ml solution 30 mg/ kg initial dose 15 mg/ kg every other week 10 weeks |
| Placebo | OTHER | Placebo comparator |
Inclusion Criteria: * Patients with Systemic Lupus Erythematosus (SLE) Exclusion Criteria: * Severe neuropsychiatric or severe renal Systemic Lupus Erythematosus (SLE) * History of chronic, recurrent, or recent severe infection * Significant hematologic abnormalities * History of cancer, heart fa...