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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02291588 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus | PHASE1 | COMPLETED | 26 | — | — | Dec 1, 2007 | Jun 1, 2010 | Nov 14, 2014 | - | — |
Subject incidence of treatment-emergent adverse events, clinically significant changes in vital signs, physical examination endpoints, clinical laboratory safety tests, and ECGs
| Arm | Type | Description |
|---|---|---|
| AMG 811 | EXPERIMENTAL | AMG 811 administered as subcutaneous and intravenous doses |
| Placebo | PLACEBO_COMPARATOR | No active drug |
| Name | Type | Description |
|---|---|---|
| AMG 811 | DRUG | A single dose of AMG 811 or placebo will be adminstered. |
| Placebo | DRUG | contains no active drug |
Inclusion Criteria: * Diagnosis of SLE ncluding a positive antinuclear antibodies (ANA) test at least 6 months before randomization; any concurrent SLE pharmacologic regimen (including leflunomide, methotrexate, and anti-malarials) was stable for at least 30 days before randomization; prednisone ≤ ...