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New hope for kids with rare blood disorders: benralizumab trial launches

NCT ID NCT06512883

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 8 times

Summary

This Phase 3 trial tests the drug benralizumab (Fasenra) in children aged 6 to 17 with two rare eosinophilic diseases: EGPA and HES. The study aims to see if the drug is safe, how it works in the body, and whether it can help control the disease. Fourteen children will receive injections every 4 weeks, with researchers monitoring side effects and remission rates.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
benralizumab (Fasenra)
What this could lead to
If successful, this could provide a treatment option to control eosinophilic diseases in children, reducing symptoms and reliance on steroids.
What could go wrong
This is a small, open-label trial with only 14 participants, so results may not apply broadly. Side effects or lack of efficacy are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 14 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

eosinophilic granulomatosis with polyangiitis hypereosinophilic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Eosinophilic granulomatosis with polyangiitis (EGPA) Hypereosinophilia syndrome (HES)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Research Site

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Research Site

    RECRUITING

    Highland Hills, Ohio, 44106-2624, United States

  • Research Site

    RECRUITING

    São Paulo, 01232-010, Brazil

  • Research Site

    RECRUITING

    Toronto, Ontario, M5G1X8, Canada

  • Research Site

    NOT_YET_RECRUITING

    Lille, 59037, France

  • Research Site

    NOT_YET_RECRUITING

    Montpellier, 34295, France

  • Research Site

    NOT_YET_RECRUITING

    Ahmedabad, 380052, India

  • Research Site

    RECRUITING

    Petah Tikva, 49202, Israel

  • Research Site

    RECRUITING

    Guadalajara, 44620, Mexico

  • Research Site

    RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • Research Site

    NOT_YET_RECRUITING

    Kielce, 25-734, Poland

  • Research Site

    NOT_YET_RECRUITING

    Warsaw, 04-730, Poland

  • Research Site

    RECRUITING

    Altındağ, 06230, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Istanbul, 34093, Turkey (Türkiye)

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