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Study on the Effectiveness and Safety of Benralizumab for Children with Severe Eosinophilic Asthma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called benralizumab in children and teenagers with severe eosinophilic asthma. Asthma is a long-term condition that affects the lungs, causing the airways to become inflamed and making it difficult to breathe. In severe cases, there are high levels of a type of white blood cell called eosinophils, which can lead to more frequent asthma attacks and worsen lung function. The purpose of this study is to evaluate how well benralizumab can reduce asthma attacks in young patients whose asthma is not well controlled.

Participants in the study will receive either benralizumab or a placebo, which is a substance with no active medication. Benralizumab is given as a solution for injection using a pre-filled syringe. The study will follow a structured plan where participants will receive regular injections and attend scheduled visits to monitor their health and the effects of the treatment. The study aims to understand if benralizumab can help reduce the number of asthma attacks and improve overall asthma control in these patients.

Throughout the study, participants will be closely monitored for any changes in their asthma symptoms and overall health. The study will also collect information on the safety of benralizumab, including any side effects that may occur. This research is important for finding better ways to manage severe eosinophilic asthma in children and teenagers, potentially leading to improved treatments in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and consent
Upon joining the study, you will attend an initial visit where you and your caregiver will be asked to provide written consent and assent. This means you agree to participate in the study and understand what it involves.
During this visit, you will be asked to complete some questionnaires about your asthma and general health. This helps the study team understand your condition better.
Step 2
Randomization and treatment assignment
After the initial assessments, you will be randomly assigned to receive either the study medication, benralizumab, or a placebo. A placebo looks like the real medication but does not contain the active ingredient.
The medication is given as a subcutaneous injection, which means it is injected under the skin. The dose is 30 mg, and it will be administered according to the study schedule.
Step 3
Treatment period
During the treatment period, you will receive the injections at regular intervals as specified by the study protocol. The exact schedule will be explained to you by the study team.
You will continue to complete daily asthma diaries and attend regular study visits to monitor your health and the effects of the treatment.
Step 4
Monitoring and assessments
Throughout the study, your asthma symptoms and overall health will be closely monitored. This includes regular check-ups and tests to assess your lung function and any changes in your condition.
You may be asked to provide blood samples to measure the levels of benralizumab and to check for any antibodies your body might produce in response to the medication.
Step 5
End of treatment and follow-up
At the end of the treatment period, you will have a final assessment to evaluate the overall effects of the study medication on your asthma.
You may be invited to participate in an open-label extension, where all participants receive the active medication, to further assess its long-term effects.

Who can join the trial?

14 criteria

The patient must be able to give assent, which means they agree to participate in the study. Their caregiver must also give written consent for the patient's participation.
The patient and their caregiver must be willing and able to answer questionnaires that are part of the study.
The patient must be a boy or girl aged between 6 and 17 years old at the time of giving assent.
The patient must have been diagnosed by a doctor with severe eosinophilic asthma for at least 12 months before the study starts. This type of asthma involves high levels of a type of white blood cell called eosinophils.
The patient must have had their severe asthma confirmed and managed by the clinical site for at least 6 months before the study starts.
The patient must have a history of asthma attacks as defined in the study protocol.
The patient must be on a stable treatment plan for asthma, which includes high doses of inhaled corticosteroids (ICS) and at least one other controller medication, such as a long-acting beta-agonist (LABA), leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonist (LAMA), or theophylline, for at least 6 months before the study starts.
The patient must have eosinophilic airway inflammation related to asthma, shown by a blood eosinophil count of at least 300 cells per microliter during screening, or a count between 150 and 299 cells per microliter with documentation of elevated eosinophils in other tests within the 2 years before the study starts.
The patient must have at least 70% compliance with their asthma medication during the screening period, based on the PASO or Asthma Daily Diary.
The patient must complete at least 70% of the PASO or Asthma Daily Diary during the entire screening period, with at least 50% completion in the 14 days before randomization.
The patient must have a pre-bronchodilator FEV1 (a measure of lung function) of 95% or less of the predicted normal value, or a pre-bronchodilator FEV1/FVC ratio of less than 0.85. If there is a 25% or more increase in this value during screening, the patient will not be eligible.
The patient must have an Asthma Control Questionnaire-IA (ACQ-IA) score of 1.5 or higher, with no meaningful improvement between screening and the second visit.
The patient must weigh at least 15 kilograms.
Females who can have children and are sexually active must agree to use a highly effective method of contraception during the study and for 12 weeks after the last dose of the investigational product.

Who cannot join the trial?

10 criteria

Patients who have other serious lung diseases besides asthma.
Patients who have had a recent infection that affects the lungs.
Patients who are currently using other medications that might interfere with the study treatment.
Patients who have a history of severe allergic reactions to medications.
Patients who have a condition that affects their immune system, which is the body's defense against infections.
Patients who are currently participating in another clinical trial.
Patients who have a history of drug or alcohol abuse.
Patients who are pregnant or breastfeeding.
Patients who have a history of cancer.
Patients who have a history of heart disease.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Bambino Gesu Childrens Hospital
Verified
Rome, Italy
Hospices Civils De Lyon
Responsive
Lyon, France
Universita' Degli Studi Di Verona
Responsive
Verona, Italy

Trial locations

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Investigated drugs

Benralizumab is a medication used in this clinical trial to help manage severe eosinophilic asthma in children and teenagers. It works by targeting and reducing the number of eosinophils, which are a type of white blood cell that can cause inflammation in the airways. By lowering the eosinophil count, benralizumab aims to decrease the frequency and severity of asthma attacks, making it easier for patients to breathe and reducing the need for other asthma medications.

Benralizumab

What is already known about the treatment

Benralizumab – Benralizumab is administered as an injection under the skin, typically in a healthcare setting. It is currently being studied in clinical trials for its effectiveness in treating severe eosinophilic asthma in children and adolescents. This medication is primarily used to reduce asthma attacks in patients with high levels of eosinophils, a type of white blood cell that can cause inflammation in the lungs. At the molecular level, benralizumab works by targeting and reducing eosinophils, helping to decrease inflammation and improve lung function. It is classified as a monoclonal antibody, a type of drug designed to target specific cells in the body.

Investigated diseases

Severe Eosinophilic Asthma – Severe eosinophilic asthma is a chronic lung condition characterized by inflammation of the airways, which are the tubes that carry air in and out of the lungs. In this form of asthma, patients have high levels of eosinophils, a type of white blood cell, in their blood. These eosinophils contribute to inflammation, leading to more frequent asthma attacks. The inflammation can also cause a decline in lung function over time. This condition is particularly challenging to manage due to the persistent and severe nature of the symptoms.