Recruiting
Phase 3

Benralizumab

Sponsor:

AstraZeneca

Code:

NCT06512883

Conditions

Eosinophilic Granulomatosis With Polyangiitis (EGPA)

Hypereosinophilia Syndrome (HES)

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Benralizumab

Study Details

Brief summary:

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

Conditions

Eosinophilic Granulomatosis With Polyangiitis (EGPA)

Hypereosinophilia Syndrome (HES)

Study ID

NCT06512883

Start date

Apr 17, 2025

Status verified date

Aug, 2026

Completion date

May 14, 2029

Anticipated

Primary completion date

Feb 20, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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, 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.

Study Design

Enrollment

14 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: EGPA/HES Cohort: Benralizumab

Participants with greater than or equal to (>=) 35 kg weight will receive benralizumab dose-1 and participants with less than (<) 35 kg weight will receive benralizumab dose-2 as SC injection Q4W during the 52-week treatment period. All participants who complete the 52-week treatment period will be offered the opportunity to continue into an extension period.

Interventions

Benralizumab

Benralizumab will be administered as SC injection on Q4W.

Primary outcome measure

  • Number of Participants with Adverse Events (AEs) [ Time Frame: From screening (Week -4 to -1) until Week 52 ]
  • Serum Concentrations of Benralizumab [ Time Frame: Weeks 0, 12, 24, 25, 36, and 52 ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Aurora, Colorado, United States, 80045

Research Site

Recruiting

Highland Hills, Ohio, United States, 44106-2624

Research Site

Recruiting

Toronto, Ontario, Canada, M5G1X8

More Information

Sponsor

AstraZeneca

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-24.