A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases

Launched by ASTRAZENECA · Jul 17, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called benralizumab to see how safe it is and how well it works for children with a condition known as Eosinophilic Granulomatosis With Polyangiitis (EGPA). The trial will include children aged 6 to under 18 years who weigh at least 15 kilograms. To be eligible, participants must have been on a stable dose of corticosteroids (a common type of medication used to reduce inflammation) for at least four weeks before joining the study.

The study is not currently recruiting participants, but when it begins, kids who qualify will be monitored closely to see how they respond to the treatment. It's important to know that certain health conditions, like any serious current or past cancers, and previous reactions to similar medications will exclude potential participants. This trial will help researchers understand how benralizumab affects young patients with EGPA, which could lead to better treatment options for this condition in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 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 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 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.