A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
NCT ID: NCT06512883
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
4 participants
INTERVENTIONAL
2025-04-17
2028-04-03
Brief Summary
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Detailed Description
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Paediatric participants with eosinophilic granulomatosis with polyangiitis (EGPA) will be enrolled in the first cohort.
Paediatric participants with hypereosinophilic syndrome (HES) will be enrolled in the second cohort. Additional cohorts in other eosinophilic diseases may be added in future protocol amendments.
The study consists of 3 periods:
1. Screening period: 1 to 4 weeks
2. Open-label treatment period: 52 weeks
3. Open-label extension period: at least 52 weeks (plus safety follow-up \[SFU\] weeks after last investigational product \[IP\] administration)
All eligible participants will receive benralizumab SC Q4W during the 52-week open-label treatment period.
All participants who complete the 52-week open-label treatment period on IP will be offered the opportunity to continue into an extension period. The extension period is intended to allow each participant at least an additional one year of treatment with benralizumab.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EGPA/HES Cohort: Benralizumab
Participants with greater than or equal to (\>=) 35 kg weight will receive benralizumab dose-1 and participants with less than (\<) 35 kg weight will receive benralizumab dose-2 as SC injection Q4W during the 52-week treatment period. All participants who complete the 52-week treatment period will be offered the opportunity to continue into an extension period.
Benralizumab
Benralizumab will be administered as SC injection on Q4W.
Interventions
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Benralizumab
Benralizumab will be administered as SC injection on Q4W.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Years
17 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Aurora, Colorado, United States
Research Site
São Paulo, , Brazil
Research Site
Toronto, Ontario, Canada
Research Site
Guadalajara, , Mexico
Research Site
Altındağ, , Turkey (Türkiye)
Research Site
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Other Identifiers
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2023-508533-14-00
Identifier Type: OTHER
Identifier Source: secondary_id
EMEA-001214-PIP09-21-M02(EGPA)
Identifier Type: OTHER
Identifier Source: secondary_id
EMEA-001214-PIP04-19-M02 (HES)
Identifier Type: OTHER
Identifier Source: secondary_id
D3255C00004
Identifier Type: -
Identifier Source: org_study_id
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