A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases

Recruiting now · Phase 3

Conditions studied: Eosinophilic Granulomatosis With Polyangiitis (EGPA), Hypereosinophilia Syndrome (HES)

In brief

The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.

Key facts

Study ID

NCT06512883

Run by

AstraZeneca

People needed

14

Starts

2025-04-17

Expected to finish

2029-05-14

Last updated by the study team

2026-07-21

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

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).
• 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.

Where it is running

• Research Site — Aurora, Colorado, United States (enrolling)
• Research Site — Highland Hills, Ohio, United States (enrolling)
• Research Site — São Paulo, Brazil (enrolling)
• Research Site — Toronto, Ontario, Canada (enrolling)
• Research Site — Petah Tikva, Israel (enrolling)
• Research Site — Guadalajara, Mexico (enrolling)
• Research Site — Altındağ, Turkey (Türkiye) (enrolling)
• Research Site — Istanbul, Turkey (Türkiye) (enrolling)
• Research Site — Cincinnati, Ohio, United States
• Research Site — Kielce, Poland
• Research Site — Warsaw, Poland
• Research Site — Rotterdam, Netherlands
• Research Site — Lille, France
• Research Site — Montpellier, France
• Research Site — Ahmedabad, India

Full record on ClinicalTrials.gov

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