A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases (NCT06512883) | Clinical Trial Compass
RecruitingPhase 3
A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
United States, Brazil, Canada14 participantsStarted 2025-04-17
Plain-language summary
The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.
Who can participate
Age range6 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,…
What they're measuring
1
Number of Participants with Adverse Events (AEs)
Timeframe: From screening (Week -4 to -1) until Week 52