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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01031836 | A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus. | PHASE2 | COMPLETED | 30 | — | — | Nov 25, 2009 | Jul 11, 2016 | Nov 19, 2018 | 7 | Japan |
| Arm | Type | Description |
|---|---|---|
| MEDI-545 1.0 mg/kg | EXPERIMENTAL | Cohort 1 |
| MEDI-545 3.0 mg/kg | EXPERIMENTAL | Cohort 2 |
| MEDI-545 10.0 mg/kg | EXPERIMENTAL | Cohort 3 |
| MEDI-545 100 mg | EXPERIMENTAL | Cohort 4 |
| MEDI-545 600 mg | EXPERIMENTAL | Cohort 5 |
| MEDI-545 1,200 mg | EXPERIMENTAL | Cohort 6 |
| Name | Type | Description |
|---|---|---|
| MEDI-545 | DRUG | Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses. |
| MEDI-545 600 | DRUG | Stage I: MEDI-545 600 mg IV once every 4 weeks from Day 1 for a total of 8 doses. Stage II: MEDI-545 600 mg IV once every 4 weeks for a total of 40 doses. |
Inclusion Criteria: * Patients must have previously met ≥4 of the 11 revised ACR criteria * Have positive antinuclear antibody test (ANA) at ≥1:80 serum dilute in the past or at screening * Have at least 1 system with a score of A or 2 systems with a score of B on the BILAG index at screening, or h...