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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02155660 | Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History | PHASE3 | COMPLETED | 2,255 | — | — | Jun 25, 2014 | Apr 9, 2018 | Jun 26, 2019 | 356 | United States, Argentina +24 |
| NCT02138916 | Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History | PHASE3 | COMPLETED | 1,656 | — | — | Jun 13, 2014 | Apr 10, 2018 | Jun 13, 2019 | 407 | United States, Austria +15 |
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...