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New hope for kids with severe asthma: drug aims to cut attacks

NCT ID NCT05692180

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Updated 2 times

Summary

This study tests whether benralizumab, an injected drug, can reduce asthma attacks in children aged 6 to 17 with severe eosinophilic asthma. About 200 participants will receive either benralizumab or a placebo, and researchers will track how long it takes for their first asthma flare-up to occur. The goal is to see if this treatment can help kids whose asthma is not well controlled with current medications.

What this could mean

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

Active substance
benralizumab
What this could lead to
If it works, this could give children with severe asthma a new treatment option that reduces flare-ups and improves daily symptoms.
What could go wrong
This is a Phase 3 trial, but results may not apply to all children. Benralizumab is already approved for adults, but its safety and effectiveness in kids are still being confirmed.

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

94 people

The number who actually took part.

Started

Apr 2023

Expected to finish

May 2032

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 18 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: * Capable of giving assent (signing the assent form) to participate in the study. The caregiver of the patient must be capable of giving written informed consent for the patient's participation in the study. Consent and assent forms must be completed prior to any study-specific procedures. * Patient and the caregiver (where applicable) must be willing to and be able to answer questionnaires that are part of the study procedures. * Male or female patients aged ≥ 6 to \< 18 years old. * Patients with physician-diagnosed severe eosinophilic asthma for at least 12 months prior to Visit 1. * Patients with a diagnosis of severe asthma confirmed, evaluated, and managed by the clinical site/site network for ≥ 6 months prior to Visit 1. * Patients with an exacerbation history of asthma exacerbations (defined as a requirement for systemic corticosteroids and/or hospitalisation) within 12 months prior to Visit 1, OR, 1. 2 asthma exacerbations (defined as a requirement for systemic corticosteroids and/or hospitalisation) per year within the 2 years prior to Visit 1 AND, one or more of the following: 2. Currently on stable maintenance oral corticosteroids (OCS) used for at least 3 months prior to Visit 1, OR, 3. At least one of the 2 exacerbations that occurred in the year prior to Visit 1 resulted in hospitalisation. * Patients on well-documented, stable treatment for asthma with high dose ICS and at least one additional controller medication, such as long-acting β2 agonists (LABA), leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA), or theophylline, since at least 6 months prior to Visit 1. * Eosinophilic airway inflammation that is related to asthma characterised as eosinophilic in nature as indicated by peripheral blood eosinophil count of ≥ 300 cells/μL during screening OR a blood eosinophil count of 150 to 299 cells/μL during screening and documentation of elevated eosinophils in bronchoalveolar lavage (BAL), sputum, bronchial biopsy, or historical eosinophil count ≥ 300 cells/μL within the 2 years prior to Visit 1. * ≥ 70% compliance with maintenance asthma medication during the screening period based on the Paediatric Asthma Symptom - Observer reported (PASO) or Asthma Daily Diary. * At least 50% daily PASO or Asthma Daily Diary completion during the entire screening period, with at least 50% PASO or Asthma Daily Diary completion in the 14-day period prior to randomisation. * ACQ-IA ≥ 1.5 at screening and Visit 2a. * Body weight ≥ 15 kg. * Females of childbearing potential (FOCBP) who are sexually active, as judged by the investigator, must commit to consistent and correct use of a highly effective method of contraception. Exclusion Criteria: * Clinically important pulmonary disease other than asthma or patients who have ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts. * Life-threatening asthma. * Asthma exacerbation requiring use of systemic corticosteroids or increase in maintenance dose of OCS within 2 weeks prior to Visit 2a or acute upper/lower respiratory infection that requires antibiotics or antiviral medication within 2 weeks prior to the first dose of the IP (Visit 2b). * Any disorder that is not stable in the opinion of the investigator and could affect the safety of the patient during the study, influence the findings of the studies or their interpretations or impede the patient's ability to complete the entire duration of the study. * History of anaphylaxis to any biologic therapy. * Current malignancy, or history of malignancy. * A helminth parasitic infection. * Use of immunosuppressive medication. * Receipt of immunoglobulin or blood products within 30 days prior to Visit 1. * Receipt of any marketed or investigational biologic within 5 half-lives prior to Visit 2. * Previously received benralizumab (MEDI-563). * Participation in another interventional clinical study. * Patients with known hypersensitivity to benralizumab or any of the excipients of the product. * Currently pregnant, breastfeeding, or lactating females. * Previous randomisation in the present study.

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Conditions

The condition(s) this trial relates to.

asthma pulmonary eosinophilia T2-high asthma

As listed by the trial registrant

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

Asthma

Contacts and locations

Locations

  • Research Site

    Torrance, California, 90505, United States

  • Research Site

    Ocala, Florida, 34471, United States

  • Research Site

    Owensboro, Kentucky, 42301, United States

  • Research Site

    Lafayette, Louisiana, 70508, United States

  • Research Site

    Kansas City, Missouri, 64108, United States

  • Research Site

    Northfield, New Jersey, 08225, United States

  • Research Site

    The Bronx, New York, 10459, United States

  • Research Site

    Cincinnati, Ohio, 45229, United States

  • Research Site

    Charleston, South Carolina, 29425, United States

  • Research Site

    San Antonio, Texas, 78229, United States

  • Research Site

    Tyler, Texas, 75708, United States

  • Research Site

    Ciudad de Buenos Aires, C1414AIF, Argentina

  • Research Site

    Ciudad de Buenos Aire, C1425DTG, Argentina

  • Research Site

    Florida, B1602DQD, Argentina

  • Research Site

    Lobos, 7240, Argentina

  • Research Site

    Mar del Plata, B7600, Argentina

  • Research Site

    Mendoza, 5500, Argentina

  • Research Site

    Mendoza, M5500CCG, Argentina

  • Research Site

    Rosario, 2000, Argentina

  • Research Site

    San Juan Bautista, 1888, Argentina

  • Research Site

    Santa Fe, S3000ASF, Argentina

  • Research Site

    Créteil, 94010, France

  • Research Site

    Lyon, 69394, France

  • Research Site

    Rouen, 76031, France

  • Research Site

    Milan, 20142, Italy

  • Research Site

    Roma, 00165, Italy

  • Research Site

    Bialystok, 15-879, Poland

  • Research Site

    Krakow, 31-624, Poland

  • Research Site

    Lodz, 90-302, Poland

  • Research Site

    Skarżysko-Kamienna, 26-110, Poland

  • Research Site

    Tarnów, 33-100, Poland

  • Research Site

    Cheongju-si, 28644, South Korea

  • Research Site

    Junggu, 22332, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Badalona, 08916, Spain

  • Research Site

    Barcelona, 8035, Spain

  • Research Site

    Benalmádena, 29631, Spain

  • Research Site

    Esplugues de Llobregat, 8950, Spain

  • Research Site

    Kaohsiung City, 833, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

  • Research Site

    London, SE5 9RS, United Kingdom

  • Research Site

    Manchester, M13 9PL, United Kingdom

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