Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Omalizumab · 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...
Omalizumab is a monoclonal antibody being developed for allergic asthma. It is currently in Phase 1 clinical development. The drug is also being studied for other allergic conditions, including atopic dermatitis and allergic rhinitis, as well as in healthy volunteers.
Omalizumab is being developed by AstraZeneca PLC, which is listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with allergic asthma and other allergic conditions.
Omalizumab is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied in a Phase 1 trial to assess its safety, tolerability, and pharmacokinetics.
Omalizumab is being studied in a Phase 1 clinical trial with the identifier NCT01544348. This is a randomized, double-blind, placebo-controlled, dose-escalation safety study in subjects with IgE levels of 30 IU/mL or higher. The trial has been completed and enrolled 295 participants.
Yes, Omalizumab is also known as MEDI4212. In clinical trials, the drug is referred to by this alternative name. The Phase 1 study NCT01544348 evaluates MEDI4212 in subjects with allergic asthma, atopic dermatitis, allergic rhinitis, and healthy volunteers.