RecruitingPhase 3
A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
AstraZeneca · NCT06512883
View Study & Apply (opens in a new tab)
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 6–17 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 14
- US sites recruiting
- 2
- Study start
- April 17, 2025
- Record last updated
- September 18, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.
Being studied: Benralizumab
Conditions: Eosinophilic Granulomatosis With Polyangiitis (EGPA); Hypereosinophilia Syndrome (HES)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Research Site
Aurora, CO 80045
Research Site
Highland Hills, OH 44106-2624
Study contacts (from the official record)
- AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com