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A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
RecruitingPhase 3
Sponsor: AstraZeneca
Conditions: Eosinophilic Granulomatosis With Polyangiitis (EGPA), Hypereosinophilia Syndrome (HES)
Interventions: Benralizumab
Countries: United States, Brazil, Canada, France, India, Israel, Mexico, Netherlands
The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.
Eligibility overview
Sex: ALL
Age: 6 Years to 17 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: All Cohorts: * Male or female participants must be aged 6 to \< 18 years of age at the time of signing the assent form and their caregiver signing the informed consent form. * Body weight greater than (\>=) 15 kilograms (kg). EGPA Cohort: * Therapy with corticosteroids: The prescribed dose of oral corticosteroids (OCS) (greater than \[\>\] 0.1 milligrams per kilogram per day (mg/kg/day), max dose of 50 milligrams per day (mg/day) must be stable (that is, no adjustment of the dose) for at least 4 weeks prior to baseline (Visit 2). * Immunosuppressive therapy: If receiving immunosuppressive therapy, the dosage must be stable for at least 4 weeks prior to baseline (Visit 2). HES Cohort: * Documented HES diagnosis, defined as history of persistent eosinophilia \>1500 cells/µL without secondary cause on 2 examinations ≥1 month apart and evidence of eosinophil-mediated organ involvement. * Symptomatic active HES, or history of a prior flare, or considered eligible based on disease severity per investigator judgement. * AEC ≥1000 cells/µL at screening (Visit 1). * Documented negative testing for Fip1-like 1 gene fused with the platelet-derived growth factor receptor alpha gene (FIP1L1-PDGFR) fusion tyrosine kinase gene translocation. Exclusion Criteria: All Cohorts: * Any current malignancy or history of malignancy. * History of anaphylaxis to any biologic therapy or vaccine. * Known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological, respiratory, or any other system abnormalities. * Previous receipt of benralizumab in an interventional clinical study. EGPA Cohort: * Diagnosed with granulomatosis with polyangiitis (previously known as Wegener'granulomatosis) or microscopic polyangiitis. * EGPA relapse: any deterioration in EGPA and/or organ-threatening EGPA that per Investigator judgement renders participants unstable in their EGPA within 3 months prior to screening (Visit 1) and through first administration of IP at baseline (Visit 2). * Life-threatening EGPA: imminently life-threatening EGPA disease within 3 months prior to screening (Visit 1) and through first administration of IP at baseline (Visit 2), as per Investigator judgement. HES Cohort: * Life-threatening HES or HES complications, as judged by the investigator. * Hypereosinophilia of unknown significance (HE-US). * Diagnosis of systemic mastocytosis.
Locations (15)
- Aurora, Colorado, United States
- Cincinnati, Ohio, United States
- Highland Hills, Ohio, United States
- São Paulo, Brazil
- Toronto, Ontario, Canada
- Lille, France
- Montpellier, France
- Ahmedabad, India
- Petah Tikva, Israel
- Guadalajara, Mexico
- Rotterdam, Netherlands
- Kielce, Poland
- Warsaw, Poland
- Altındağ, Turkey (Türkiye)
- Istanbul, Turkey (Türkiye)