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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02411136 | A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus | PHASE1 | COMPLETED | 64 | — | — | May 1, 2005 | Oct 1, 2007 | Apr 8, 2015 | - | — |
| NCT02443506 | A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose of AMG 623 in Subjects With Systemic Lupus Erythematosus | PHASE1 | COMPLETED | 56 | — | — | Oct 1, 2004 | Jun 1, 2007 | May 14, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| AMG 623 | EXPERIMENTAL | Multiple doses of AMG 623 administered as subcutaneous and intravenous doses |
| Placebo | PLACEBO_COMPARATOR | Multiple doses of AMG 623 administered as subcutaneous and intravenous doses |
| Name | Type | Description |
|---|---|---|
| AMG 623 | DRUG | Multiple doses of AMG 623 administered as subcutaneous and intravenous doses |
| Placebo | DRUG | Multiple doses of AMG 623 administered as subcutaneous and intravenous doses |
Inclusion Criteria: * Men and women between the ages of 18 and 65 years old * Diagnosis of SLE * Stable disease; defined as no change in SLE therapy within the previous 30 days. Up to 5 mg/day incremental changes of prednisone therapy is allowed during the 30 days prior to randomization * SLE disea...