Investigating benralizumab for children with eosinophilic diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multicenter trial evaluates the safety, pharmacokinetics, pharmacodynamics, efficacy, and immunogenicity of benralizumab administered subcutaneously every four weeks in children aged 6 to under 18 with eosinophilic granulomatosis with polyangiitis (EGPA). The study consists of a screening period, a 52-week treatment period, and an optional extension period for continued treatment. Participants will receive benralizumab during the treatment phase, with the possibility of extending their participation for an additional year. The trial aims to gather comprehensive data on the drug's effects in this pediatric population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Aurora, Colorado, United States Recruiting
• Research Site
  Cincinnati, Ohio, United States Recruiting
• Research Site
  Highland Hills, Ohio, United States Recruiting
• Research Site
  São Paulo, Brazil Recruiting
• Research Site
  Toronto, Ontario, Canada Recruiting
• Research Site
  Lille, France Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Benralizumab in EGPA: real-world effectiveness and safety

  This is a real-world study checking how well and safely benralizumab works for adults with eosinophilic granulomatosis with polyangiitis (EGPA).

  Recruiting European EGPA Study Group · Florence, Italy · NCT07815886

• Continued benralizumab for participants who completed a prior benralizumab study

  This trial tests continuing benralizumab in people who benefited from it in a previous study, to see if long-term treatment is safe and tolerable.

  Recruiting at 20 sites Phase 3 AstraZeneca · Aurora, Colorado and 45 other locations · NCT07444567

• Benralizumab treatment for adults with ABPA and severe asthma

  This will test whether benralizumab helps adults (18–75) who have severe asthma with allergic bronchopulmonary aspergillosis (ABPA).

  Recruiting at 2 sites Qianfoshan Hospital · Jinan, Shandong and 1 other locations · NCT07530770

• Real-world benralizumab treatment for adults with severe eosinophilic asthma in Italy

  This study will test whether benralizumab helps adults with severe eosinophilic asthma reach partial or complete clinical remission during routine care in Italy.

  Recruiting at 12 sites AstraZeneca · Salerno, Battipaglia and 27 other locations · NCT07214753

• Real-world use of benralizumab in Chinese patients with severe eosinophilic asthma

  See how benralizumab works for people in China aged 12 and up with severe eosinophilic asthma when given as part of routine care.

  Recruiting at 36 sites AstraZeneca · Anning and 35 other locations · NCT06862206

• Observational study on asthma control with benralizumab

  This study is testing how well benralizumab helps people with severe eosinophilic asthma manage their symptoms and improve their quality of life over a year.

  Recruiting at 40 sites AstraZeneca · Ahrensburg and 40 other locations · NCT06422078

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.