Phase 3 Open-Label Study of Benralizumab Safety and Effectiveness in Children Ages 6 to 17 With Rare Eosinophilic Diseases

What this Trial Is About

Researchers are evaluating benralizumab in children aged 6 to under 18 years with rare eosinophilic diseases, including eosinophilic granulomatosis with polyangiitis EGPA and hypereosinophilic syndrome HES. The study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, efficacy, and immunogenicity of repeated dosing of benralizumab given every 4 weeks. This open-label, multicenter Phase 3 trial enrolls pediatric participants and may add additional cohorts for other eosinophilic diseases in the future. Participants will receive benralizumab as a subcutaneous injection every 4 weeks during a 52-week open-label treatment period. Dosing depends on weight those weighing 35 kg or more receive one dose level, and those under 35 kg receive a different dose. Participants who complete the initial 52 weeks may continue into an extension period to receive at least an additional year of benralizumab treatment. The study includes three periods screening 1 to 4 weeks, treatment 52 weeks, and an open-label extension period at least 52 weeks plus safety follow-up. During the study, participants will be monitored regularly for adverse events and blood levels of benralizumab at specific weeks. Additional assessments include evaluating disease remission, eosinophil counts, antidrug antibodies, and flare-ups or relapses related to EGPA or HES. Patient-reported outcomes like the Patient Global Impression of Change are also collected. Safety follow-up occurs after the last dose, with study participation lasting multiple years depending on extension enrollment.

A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases