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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00436670 | Phase II Study to Evaluate the Efficacy of AMG 317 | PHASE2 | COMPLETED | 294 | — | — | Mar 1, 2007 | Feb 1, 2009 | Mar 23, 2016 | - | — |
| Arm | Type | Description |
|---|---|---|
| AMG 317 75 mg | EXPERIMENTAL | 75 subjects |
| Placebo Arm | PLACEBO_COMPARATOR | 75 subjects |
| AMG 317 300 mg | EXPERIMENTAL | 75 subjects |
| AMG 317 150 mg | EXPERIMENTAL | 75 subjects |
| Name | Type | Description |
|---|---|---|
| AMG 317 75 mg | BIOLOGICAL | 75 mg SC weekly injection |
| AMG 317 150 mg | BIOLOGICAL | 150 mg SC once weekly injection |
| AMG 317 300 mg | BIOLOGICAL | 300 mg weekly SC injection |
| Placebo | BIOLOGICAL | Placebo SC once weekly injection |
Inclusion Criteria: * Males or females 18 to 65 years of age at the time of screening * Baseline percent of predicted FEV1 ≥ 50% to ≤ 80% at screening * At least 12% reversibility over baseline FEV1 with beta agonist inhalation, which can be demonstrated in the office or documented by medical recor...