Status:
RECRUITING
A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
Lead Sponsor:
AstraZeneca
Conditions:
Eosinophilic Granulomatosis With Polyangiitis (EGPA)
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
The main purpose of study is to assess the safety, tolerability, and pharmacokinetic (PK) of benralizumab.
Detailed Description
This study is open-label, multicentre, basket study to evaluate the safety, PK, pharmacodynamic (PD), efficacy, and immunogenicity of repeat dosing of benralizumab subcutaneous (SC) every 4 weeks (Q4W...
Eligibility Criteria
Inclusion
- All Cohorts:
- Male or female patients 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).
Exclusion
- 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 patients 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.
Key Trial Info
Start Date :
April 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 29 2027
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT06512883
Start Date
April 17 2025
End Date
December 29 2027
Last Update
December 12 2025
Active Locations (6)
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1
Research Site
Aurora, Colorado, United States, 80045
2
Research Site
São Paulo, Brazil, 01232-010
3
Research Site
Toronto, Ontario, Canada, M5G1X8
4
Research Site
Guadalajara, Mexico, 44620