Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Benralizumab Arm A · 2 trials · 1 indication
A COPD exacerbation is defined by symptomatic worsening of COPD requiring: * Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or * Use of antibiotics; and/or * An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.
| Arm | Type | Description |
|---|---|---|
| Benralizumab Arm A | EXPERIMENTAL | Benralizumab administered subcutaneously |
| Benralizumab Arm B | EXPERIMENTAL | Benralizumab administered subcutaneously |
| Benralizumab Arm C | EXPERIMENTAL | Benralizumab administered subcutaneously |
| Placebo | PLACEBO_COMPARATOR | Placebo administered subcutaneously |
| Name | Type | Description |
|---|---|---|
| Benralizumab Arm A | DRUG | Benralizumab subcutaneously on study week 0 until study week 48 inclusive |
| Benralizumab Arm B | DRUG | Benralizumab subcutaneously on study week 0 until study week 48 inclusive |
| Benralizumab Arm C | DRUG | Benralizumab subcutaneously on study week 0 until study week 48 inclusive |
| Placebo | DRUG | Benralizumab subcutaneously on study week 0 until study week 48 inclusive |
Inclusion Criteria:. * Informed consent. * Subjects 40-85 y.o. * Moderate to very severe COPD with Post Bronchodilator (BD) FEV1\>20% and ≤65%. -≥2 moderate or ≥1 severe COPD exacerbation(s) required treatment or hospitalization within 2-52 weeks prior to Visit1. * Modified Medical Research Coun...
Benralizumab Arm A is an investigational small molecule being studied for the treatment of moderate to very severe chronic obstructive pulmonary disease (COPD) with a history of exacerbations. It is developed by AstraZeneca PLC (AZN) and is currently in Phase 3 clinical development, though the trials have been completed.
Benralizumab Arm A is developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is being investigated for the treatment of moderate to very severe chronic obstructive pulmonary disease with exacerbation history.
Benralizumab Arm A is in Phase 3 clinical development. Two Phase 3 trials have been completed, with a total enrollment of 3,911 participants. The drug is investigational and has not been approved by regulatory authorities.
Benralizumab Arm A has been studied in two completed Phase 3 trials: NCT02138916 with 1,656 participants and NCT02155660 with 2,255 participants. Both trials evaluated the drug in patients with moderate to very severe chronic obstructive pulmonary disease with exacerbation history.
Benralizumab Arm A is a specific arm of a clinical trial program evaluating benralizumab, an investigational drug. The name 'Benralizumab Arm A' refers to one treatment group within the Phase 3 studies, while benralizumab is the active substance being tested.