RecruitingPhase 3NCT06512883

A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases

Phase 3, Open-label Trial to Evaluate Safety, Pharmacokinetics, and Efficacy of Benralizumab in Children With Eosinophilic Diseases (CLIPS)


Sponsor

AstraZeneca

Enrollment

14 participants

Start Date

Apr 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 6 YearsMax Age: 17 Years

Inclusion Criteria11

  • 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 Criteria13

  • 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.

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Interventions

DRUGBenralizumab

Benralizumab will be administered as SC injection on Q4W.


Locations(13)

Research Site

Aurora, Colorado, United States

Research Site

Cincinnati, Ohio, United States

Research Site

Highland Hills, Ohio, United States

Research Site

São Paulo, Brazil

Research Site

Toronto, Ontario, Canada

Research Site

Lille, France

Research Site

Montpellier, France

Research Site

Ahmedabad, India

Research Site

Guadalajara, Mexico

Research Site

Rotterdam, Netherlands

Research Site

Kielce, Poland

Research Site

Altındağ, Turkey (Türkiye)

Research Site

Istanbul, Turkey (Türkiye)

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Visit

NCT06512883


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