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A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases

NCT06512883

RecruitingPhase 3

Sponsor: AstraZeneca

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

Interventions: Benralizumab

Countries: United States, Brazil, Canada, France, India, Israel, Mexico, Netherlands

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

Eligibility overview

Sex: ALL

Age: 6 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 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.
Locations (15)
  • Aurora, Colorado, United States
  • Cincinnati, Ohio, United States
  • Highland Hills, Ohio, United States
  • São Paulo, Brazil
  • Toronto, Ontario, Canada
  • Lille, France
  • Montpellier, France
  • Ahmedabad, India
  • Petah Tikva, Israel
  • Guadalajara, Mexico
  • Rotterdam, Netherlands
  • Kielce, Poland
  • Warsaw, Poland
  • Altındağ, Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)