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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01544348 | A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL | PHASE1 | COMPLETED | 295 | — | — | Jan 1, 2012 | Jun 1, 2013 | Dec 30, 2014 | 7 | United States |
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 85 that were absent before treatment or that worsened relative to pre-treatment state.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1. |
| Omalizumab | ACTIVE_COMPARATOR | A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1. |
| MEDI4212 5 mg Subcutaneous | EXPERIMENTAL | A single dose of MEDI4212 5 mg injection subcutaneously on Day 1. |
| MEDI4212 15 mg Subcutaneous | EXPERIMENTAL | A single dose of MEDI4212 15 mg injection subcutaneously on Day 1. |
| MEDI4212 60 mg Subcutaneous | EXPERIMENTAL | A single dose of MEDI4212 60 mg injection subcutaneously on Day 1. |
| MEDI4212 150 mg Subcutaneous | EXPERIMENTAL | A single dose of MEDI4212 150 mg injection subcutaneously on Day 1. |
| MEDI4212 300 mg Subcutaneous | EXPERIMENTAL | A single dose of MEDI4212 300 mg injection subcutaneously on Day 1. |
| MEDI4212 300 mg Intravenous | EXPERIMENTAL | A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1. |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1. |
| Omalizumab | BIOLOGICAL | A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1. |
| MEDI4212 5 mg Subcutaneous | BIOLOGICAL | A single dose of MEDI4212 5 mg injection subcutaneously on Day 1. |
| MEDI4212 15 mg Subcutaneous | BIOLOGICAL | A single dose of MEDI4212 15 mg injection subcutaneously on Day 1. |
| MEDI4212 60 mg Subcutaneous | BIOLOGICAL | A single dose of MEDI4212 60 mg injection subcutaneously on Day 1. |
| MEDI4212 150 mg Subcutaneous | BIOLOGICAL | A single dose of MEDI4212 150 mg injection subcutaneously on Day 1. |
| MEDI4212 300 mg Subcutaneous | BIOLOGICAL | A single dose of MEDI4212 300 mg injection subcutaneously on Day 1. |
| MEDI4212 300 mg Intravenous | BIOLOGICAL | A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1. |
Inclusion Criteria: * Age 18 through 60 years * Written informed consent and any locally required authorization * Body weight 45-150 kilogram (kg) for Cohorts 1-3, 4b, and 5-9. Body weight 45-90 kg for Cohort 4a * Females must have been surgically sterilized or postmenopausal * Non-sterilized males...