Eosinophilic Granulomatosis With Polyangiitis (EGPA)Hypereosinophilia Syndrome (HES)
Investigational drug(s) / intervention(s)
Benralizumab
Benralizumab: Benralizumab will be administered as SC injection on Q4W.
Study summary
The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.
Eligibility
Sex
ALL
Min age
6 Years
Max age
17 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of Participants with Adverse Events (AEs) — From screening (Week -4 to -1) until Week 52 The safety and tolerability of benralizumab will be evaluated.
Serum Concentrations of Benralizumab — Weeks 0, 12, 24, 25, 36, and 52 The PK of benralizumab will be evaluated.
Trial sites (15)
Facility
City
Region
Status
Research Site
Aurora
Colorado
Recruiting
Research Site
Cincinnati
Ohio
Not Yet Recruiting
Research Site
Highland Hills
Ohio
Recruiting
Research Site
São Paulo
Brazil
Recruiting
Research Site
Toronto
Ontario
Recruiting
Research Site
Lille
France
Not Yet Recruiting
Research Site
Montpellier
France
Not Yet Recruiting
Research Site
Ahmedabad
India
Not Yet Recruiting
Research Site
Petah Tikva
Israel
Recruiting
Research Site
Guadalajara
Mexico
Recruiting
Research Site
Rotterdam
Netherlands
Recruiting
Research Site
Kielce
Poland
Not Yet Recruiting
Research Site
Warsaw
Poland
Not Yet Recruiting
Research Site
Altındağ
Turkey (Türkiye)
Recruiting
Research Site
Istanbul
Turkey (Türkiye)
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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