drugset / Trial / NCT05692180
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A study to evaluate the efficacy and safety of benralizumab administered subcutaneously in patients ≥ 6 to \< 18 years of age with severe eosinophilic asthma, including a well-documented history of asthma exacerbations and uncontrolled asthma receiving high-dose inhaled corticosteroid (ICS) plus at least one additional controller medication.
Timeline
- Start
- 2023-04-05
- Primary completion
- 2030-05-05
- Completion
- 2032-05-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Benralizumab | Monoclonal antibody | — | Subcutaneous |