Phase III, Open-label Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, Efficacy, and Immunogenicity of Benralizumab in Children with Eosinophilic Disease (CLIPS)

Condition studied

Eosinophilic Disease

Investigational medicinal product(s)

Eligibility

Primary endpoint

All cohorts: Nimber of Participants with Adverse Events (AEs), All cohorts:Serum Concentrations of Benralizumab

Endpoint detail

All cohorts: Presence and characterisation of ADA, All cohorts:Change From Baseline in Peripheral Blood Eosinophil Count, EGPA Cohort: Proportion of participants in remission at Week 24, with remission defined as PVAS = 0 and OCS intake ≤ 0.1 mg/kg/day., EGPA Cohort:Time from enrolment to first EGPA relapse, where relapse is defined as any of the following:a)Active vasculitis(PVAS > 0);OR b)Worsening of asthma symptoms (based on Asthma Control Questionnaire - Interviewer Administered [ACQ-IA]); OR c) Active nasal and/or sinus disease with worsening in at least one sino-nasal symptom question warranting any of the following: 1) Increase OCS; OR 2) Increase/addition of immunosuppressive medication; OR 3) Hospitalisation related to EGPA wors, HES Cohort:-Time to first HES worsening/flare during the Treatment Period -Proportion of participants who experience a HES worsening/flare during the treatment period - Number of HES worsening/flares (annualised rate/year) during the treatment period, HES Cohort: Number and proportion of participants who require an increase in corticosteroid dose from baseline at any point in the Treatment Period, HES Cohort:-Time to first haematologic relapse (AEC ≥ 1000 cells/μL) during the treatment period - Proportion of participants who have haematologic relapse duringthe treatment period - Number and proportion of participants who have AEC < 500 cells/μL for 24 weeks during the treatment period, HES Cohort: PGI-C during the treatment period