Approval Probability
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ML Risk
AMG 403 · 2 trials · 2 indications
Subject incident of treatment-emergent adverse events, clinically significant changes in vital signs, physical examinations endpoints, clinical laboratory safety tests, and ECGs
Vital signs to be assessed included temperature, respiratory rate, pulse rate and rhythm (regular/irregular), and blood pressure. Generally, abnormal vital signs were only reported as adverse events if they required treatment or were associated with an adverse event.
Laboratory abnormalities were defined by laboratory normal ranges and were not reported as adverse events unless symptomatic or associated with an adverse event.
ECG abnormalities were reported as adverse events if they represented a change from baseline or if associated with symptoms or an adverse event.
| 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 \>...
AMG 403 is an investigational small molecule being developed for chronic pain and osteoarthritis. It has been studied in clinical trials for osteoarthritis knee pain and in healthy subjects for chronic pain, though it remains in Phase 1 development and is not yet approved.
AMG 403 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The drug is currently in Phase 1 clinical development.
AMG 403 is in Phase 1 clinical development. It has completed two Phase 1 trials, one in subjects with osteoarthritis knee pain and one in healthy subjects, but it is not yet approved and remains investigational.
AMG 403 has been studied in two completed Phase 1 trials: NCT02318407, which evaluated safety, tolerability, and pharmacokinetics in subjects with osteoarthritis knee pain, and NCT02348879, which examined safety, pharmacokinetics, and pharmacodynamics in healthy subjects.
AMG 403 is the primary name for this investigational drug. No alternative names have been reported in clinical trial records, so it is not known to be the same as any other marketed or investigational agent.