Highland Hills

Researchers are evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), efficacy, and immunogenicity of benralizumab in children with rare eosinophilic diseases. This open-label, multicenter basket study includes pediatric participants with eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES), with plans to add other eosinophilic disease cohorts in future amendments. The trial is a phase 3 study designed to understand the effects of repeat dosing of benralizumab on these conditions. Participants will receive benralizumab as a subcutaneous injection every 4 weeks during a 52-week open-label treatment period. Those who complete this period may continue receiving benralizumab in an extension phase lasting at least an additional 52 weeks, followed by a safety follow-up period after the last dose. The dosing schedule and treatment duration are consistent for all eligible participants throughout the study. During the study, participants will be monitored for adverse events from screening through week 52, and serum benralizumab concentrations will be measured at weeks 0, 12, 24, 25, 36, and 52. The study involves a screening period of 1 to 4 weeks before treatment starts, followed by the treatment and extension phases. Researchers will assess safety, drug levels, and treatment effectiveness while tracking participants' response and tolerability over time.