A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
Start Date
4/17/2025
Completion Date
5/14/2029
Summary
The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.
Detailed Description
This study is open-label, multicentre, basket study to evaluate the safety, PK, pharmacodynamic (PD), efficacy, and immunogenicity of repeat dosing of benralizumab subcutaneous (SC) every 4 weeks (Q4W) in male and female children with rare eosinophilic diseases. Paediatric participants with eosinophilic granulomatosis with polyangiitis (EGPA) will be enrolled in the first cohort. Paediatric participants with hypereosinophilic syndrome (HES) will be enrolled in the second cohort. Additional cohorts in other eosinophilic diseases may be added in future protocol amendments. The study consists of 3 periods: 1. Screening period: 1 to 4 weeks 2. Open-label treatment period: 52 weeks 3. Open-label extension period: at least 52 weeks (plus safety follow-up \[SFU\] weeks after last investigational product \[IP\] administration) All eligible participants will receive benralizumab SC Q4W during the 52-week open-label treatment period. All participants who complete the 52-week open-label treatment period on IP will be offered the opportunity to continue into an extension period. The extension period is intended to allow each participant at least an additional one year of treatment with benralizumab.
Eligibility Criteria
Age Range: 6 years to 17 years
Interventions
Benralizumab
Conditions
Locations
Research Site
Aurora, Colorado 80045
United States
Research Site
Cincinnati, Ohio 45229
United States
Research Site
Highland Hills, Ohio 44106-2624
United States
Research Site
São Paulo, 01232-010
Brazil
Research Site
Toronto, Ontario M5G1X8
Canada
Research Site
Lille, 59037
France
Research Site
Montpellier, 34295
France
Research Site
Ahmedabad, 380052
India
Research Site
Petah Tikva, 49202
Israel
Research Site
Guadalajara, 44620
Mexico
Research Site
Rotterdam, 3015 GD
Netherlands
Research Site
Kielce, 25-734
Poland
Research Site
Warsaw, 04-730
Poland
Research Site
Altındağ, 06230
Turkey (Türkiye)
Research Site
Istanbul, 34093
Turkey (Türkiye)