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

NCT05692180

Phase 3 Active not recruiting 94 enrolled AstraZeneca Parexel · collab
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

EvaluationDrugModalityDoseRoute
Subject Benralizumab Monoclonal antibody Subcutaneous

Indications