Actively Recruiting
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
Eligibility Criteria
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
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
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
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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