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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02318407 | A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 403 in Subjects With Osteoarthritis Knee Pain | PHASE1 | COMPLETED | 24 | — | — | Dec 1, 2006 | Mar 1, 2008 | Dec 17, 2014 | - | — |
Subject incident of treatment-emergent adverse events, clinically significant changes in vital signs, physical examinations endpoints, clinical laboratory safety tests, and ECGs
| Arm | Type | Description |
|---|---|---|
| AMG 403 | EXPERIMENTAL | AMG 403 administered as subcutaneous doses |
| Placebo | PLACEBO_COMPARATOR | No active drug |
| Name | Type | Description |
|---|---|---|
| AMG 403 | DRUG | AMG 403 for the treatment of subjects with osteoarthritis |
| Placebo | DRUG | contains no active drug |
Inclusion Criteria: * Diagnosed with knee OA as determined by ACR criteria: Knee pain and radiographic osteophytes and at least 1 of the following 2 items: Morning stiffness 30 minutes, Crepitus on motion, a VAS pain score of ≥ 30 mm for index knee at screening, Exclusion Criteria: * Weight of \>...