Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI4212 · 1 trial · 4 indications
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...
MEDI4212 is an investigational monoclonal antibody being studied for allergic asthma. It has also been evaluated in atopic dermatitis, allergic rhinitis, and healthy volunteers. It is not approved and remains in clinical development.
MEDI4212 targets immunoglobulin E, or IgE, acting as an inhibitor of the IGHE target. By binding IgE, it is designed to reduce IgE-mediated allergic responses. This mechanism is relevant to allergic asthma and other allergic conditions.
MEDI4212 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program for this monoclonal antibody.
MEDI4212 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program has been completed.
MEDI4212 has been studied in one completed Phase 1 trial, NCT01544348. This randomized, double-blind, placebo-controlled dose-escalation study enrolled 295 participants with IgE levels of 30 IU/mL or higher, including those with allergic asthma, atopic dermatitis, allergic rhinitis, and healthy volunteers, in the United States.