Benralizumab for Eosinophilic Diseases in Children

A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases

Recruiting Phase 3 Interventional Study
Eosinophilic Granulomatosis With Polyangiitis (EGPA) Hypereosinophilia Syndrome (HES)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

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At a Glance
Age
6 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
14 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for

This trial is looking for children aged 6 to 18 with eosinophilic diseases. Participants will take part in assessing a medication called benralizumab for safety and effectiveness.

Are You a Good Fit for This Trial?
Rules you out Granulomatosis with polyangiitisMicroscopic polyangiitisLife-threatening hypereosinophiliaSystemic mastocytosis

You may be able to join if

  • I am aged 6 to under 18 years old.
  • I weigh more than 15 kilograms.
  • I have been diagnosed with eosinophilic granulomatosis with polyangiitis or hypereosinophilia syndrome.
  • I have stable corticosteroid therapy for at least 4 weeks.
  • I have a documented diagnosis of hypereosinophilia syndrome.
  • I have active symptoms or a history of flare-ups.

You may not be able to join if

  • I have any current malignancy or history of malignancy.
  • I have had an allergic reaction to any biologic therapy or vaccine.
  • I have significant clinical issues related to my endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, hematological, respiratory, or other systems.
  • I have taken benralizumab in another clinical study.
  • I have had life-threatening conditions related to eosinophilic diseases.
  • I have hypereosinophilia of unknown significance.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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

Trial Locations
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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 p…
Contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

CONTACT