Benralizumab for Eosinophilic Diseases in Children
A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
Recruiting
Phase 3Interventional Study
Eosinophilic Granulomatosis With Polyangiitis (EGPA)Hypereosinophilia Syndrome (HES)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
6 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
14 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for children aged 6 to 18 with eosinophilic diseases. Participants will take part in assessing a medication called benralizumab for safety and effectiveness.
Are You a Good Fit for This Trial?
Rules you outGranulomatosis with polyangiitisMicroscopic polyangiitisLife-threatening hypereosinophiliaSystemic mastocytosis
You may be able to join if
I am aged 6 to under 18 years old.
I weigh more than 15 kilograms.
I have been diagnosed with eosinophilic granulomatosis with polyangiitis or hypereosinophilia syndrome.
I have stable corticosteroid therapy for at least 4 weeks.
I have a documented diagnosis of hypereosinophilia syndrome.
I have active symptoms or a history of flare-ups.
You may not be able to join if
I have any current malignancy or history of malignancy.
I have had an allergic reaction to any biologic therapy or vaccine.
I have significant clinical issues related to my endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, hematological, respiratory, or other systems.
I have taken benralizumab in another clinical study.
I have had life-threatening conditions related to eosinophilic diseases.
I have hypereosinophilia of unknown significance.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.
Trial Locations
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Status
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 p…
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.
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