A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
This study is for children aged 6 to 17 who have a rare blood condition called Eosinophilic Granulomatosis With Polyangiitis (EGPA) or Hypereosinophilia Syndrome (HES). These conditions are linked to too many white blood cells called eosinophils. Researchers are testing a medicine called benralizumab to see how safe it is, if it helps to control the conditions, and how the body processes it. This involves children receiving benralizumab injections regularly over a long period. The study aims to gather important information to help children with these rare conditions in the future.
At a glance
What is this study about?
This study is investigating a new medicine called benralizumab for children and teenagers aged between 6 and 17 years old. The children taking part have one of two rare blood conditions: Eosinophilic Granulomatosis With Polyangiitis (EGPA) or Hypereosinophilia Syndrome (HES).
Both EGPA and HES are conditions where the body produces too many of a certain type of white blood cell called eosinophils. These extra cells can cause inflammation and damage to different parts of the body. Benralizumab is a medicine designed to reduce the number of these eosinophil cells. The main goal of this study is to understand if this medicine is safe for young people with these conditions, and to see how well it works in controlling their symptoms and condition.
Researchers will also be looking at how the body handles benralizumab and how it affects the eosinophil cells over time. This information is really important because it helps doctors understand the best way to use the medicine and if it could become a helpful treatment option for children with EGPA and HES in the future.
Key takeaways
- Study for children aged 6-17 with rare conditions EGPA or HES.
- Tests a medicine called benralizumab given by injection.
- Aims to check safety and how well the medicine works.
- The main treatment period lasts about one year.
- Children may be able to continue treatment for longer.
- All eligible participants will receive the study medicine.
Who may be eligible?
This study is looking for children and teenagers who are between 6 and 17 years old and weigh at least 15 kilograms (about 2 stone 5 pounds).
If your child has EGPA, they will need to have been on a stable dose of certain medications (oral corticosteroids and/or immunosuppressive therapy) for at least 4 weeks before starting the study treatments. If your child has HES, they must have a clear diagnosis of HES with certain test results showing high levels of eosinophils and signs that the condition is affecting their body. They must also have tested negative for a specific gene change called FIP1L1-PDGFR.
Children cannot take part if they have or have had cancer, or if they have ever had a serious allergic reaction to other similar medicines or vaccines. They also can't join if they have any other serious ongoing health issues like severe problems with their heart, liver, or kidneys, or if they have previously received benralizumab in another study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is your child aged between 6 and 17 years old?
- Does your child weigh at least 15 kilograms?
- Has your child been diagnosed with EGPA or HES?
- Has your child never had cancer?
- Has your child never had a very severe allergic reaction to a medicine or vaccine?
- Has your child not taken benralizumab in a previous study?
What does participation involve?
If your child joins the study, they would first have a screening period lasting 1 to 4 weeks. During this time, doctors will do tests to make sure they are suitable for the study. If eligible, your child would then receive the study medicine, benralizumab, as an injection under the skin every 4 weeks for a total of 52 weeks (about one year).
After this first year, if your child has responded well and is still receiving the injections, they will be given the option to continue receiving benralizumab for at least another year in an 'extension period'. Throughout the study and for a short time afterwards, there will be safety check-ups to monitor your child's health.
Potential risks and benefits
Locations (15)
- Research SiteVerified postcodeAurora, United States· Recruiting
- Research SiteVerified postcodeCincinnati, United States· Not yet recruiting
- Research SiteVerified postcodeHighland Hills, United States· Recruiting
- Research SiteVerified postcodeSão Paulo, Brazil· Recruiting
- Research SiteVerified postcodeToronto, Canada· Recruiting
- Research SiteVerified postcodeLille, France· Not yet recruiting
- Research SiteVerified postcodeMontpellier, France· Not yet recruiting
- Research SiteVerified postcodeAhmedabad, India· Not yet recruiting
- Research SiteVerified postcodePetah Tikva, Israel· Not yet recruiting
- Research SiteVerified postcodeGuadalajara, Mexico· Recruiting
- Research SiteVerified postcodeRotterdam, Netherlands· Not yet recruiting
- Research SiteVerified postcodeKielce, Poland· Not yet recruiting
Common questions
What are EGPA and HES?
They are rare conditions where there are too many white blood cells called eosinophils, which can cause health problems.
What is benralizumab?
It's a medicine being tested that aims to lower the number of these eosinophil cells in the body.
How is the medicine given?
It's given as an injection under the skin every four weeks.
How long does the study last?
The main part of the study is about one year, but children may have the option to continue treatment for longer.
Will my child definitely get the study medicine?
Yes, all eligible children in this study will receive benralizumab.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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