Actively Recruiting

Phase 3
Age: 6Years - 17Years
All Genders
NCT06512883

A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases

Led by AstraZeneca · Updated on 2026-04-17

14

Participants Needed

15

Research Sites

154 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases

Who Can Participate

Age: 6Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female participants aged 6 to under 18 years at assent signing with caregiver consent
  • Body weight of 15 kilograms or more
  • For EGPA cohort: stable oral corticosteroid dose (>0.1 mg/kg/day, max 50 mg/day) for at least 4 weeks before baseline
  • For EGPA cohort: stable immunosuppressive therapy dose for at least 4 weeks before baseline if receiving
  • For HES cohort: documented diagnosis of HES with persistent eosinophilia >1500 cells/µL on 2 exams at least 1 month apart and eosinophil-related organ involvement
  • For HES cohort: symptomatic active HES, prior flare history, or eligible per investigator judgment
  • For HES cohort: absolute eosinophil count (AEC) ≥1000 cells/µL at screening
  • For HES cohort: documented negative test for FIP1L1-PDGFR fusion gene translocation
Not Eligible

You will not qualify if you...

  • Current or past malignancy
  • History of anaphylaxis to any biologic therapy or vaccine
  • Known significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, hematological, respiratory, or other system abnormalities
  • Prior use of benralizumab in an interventional clinical study
  • For EGPA cohort: diagnosis of granulomatosis with polyangiitis or microscopic polyangiitis
  • For EGPA cohort: EGPA relapse or organ-threatening disease causing instability within 3 months before screening through baseline
  • For EGPA cohort: imminently life-threatening EGPA within 3 months before screening through baseline
  • For HES cohort: life-threatening HES or complications as judged by investigator
  • For HES cohort: hypereosinophilia of unknown significance
  • For HES cohort: diagnosis of systemic mastocytosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

Research Site

Aurora, Colorado, United States, 80045

Actively Recruiting

2

Research Site

Cincinnati, Ohio, United States, 45229

Not Yet Recruiting

3

Research Site

Highland Hills, Ohio, United States, 44106-2624

Not Yet Recruiting

4

Research Site

São Paulo, Brazil, 01232-010

Actively Recruiting

5

Research Site

Toronto, Ontario, Canada, M5G1X8

Actively Recruiting

6

Research Site

Lille, France, 59037

Not Yet Recruiting

7

Research Site

Montpellier, France, 34295

Not Yet Recruiting

8

Research Site

Ahmedabad, India, 380013

Not Yet Recruiting

9

Research Site

Petah Tikva, Israel, 49202

Not Yet Recruiting

10

Research Site

Guadalajara, Mexico, 44620

Actively Recruiting

11

Research Site

Rotterdam, Netherlands, 3015 GD

Not Yet Recruiting

12

Research Site

Kielce, Poland, 25-734

Not Yet Recruiting

13

Research Site

Warsaw, Poland, 04-730

Not Yet Recruiting

14

Research Site

Altındağ, Turkey (Türkiye), 06230

Actively Recruiting

15

Research Site

Istanbul, Turkey (Türkiye), 34093

Actively Recruiting

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Research Team

A

AstraZeneca Clinical Study Information Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases | DecenTrialz