RecruitingEosinophilic Granulomatosis With Polyangiitis (EGPA)Hypereosinophilia Syndrome (HES)
A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
Eligible age
6–17 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.
Sponsor: AstraZeneca
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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).
Where it's recruiting
Source: ClinicalTrials.gov · NCT06512883 · last updated 2026-08-24