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Clinical Trials in India / NCT06512883
Recruiting Phase 3

A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases

NCT06512883 · tracked via the Priya Life Science India tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2025-04-17
Last updated
2026-08-24

Condition(s) studied

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)

Trial sites (15)

FacilityCityRegionStatus
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.

View NCT06512883 on ClinicalTrials.gov ↗ ← All trials in India