A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma

This study is looking for children aged 5 to 11 who have been diagnosed with severe asthma for at least six months. They need to be taking high-dose inhaled steroids and at least one other asthma controller medicine.

To be eligible, there must be clear evidence from their medical history, like breathing tests or lung function tests, showing that their asthma is severe and not fully controlled. For example, they might have had certain breathing test results or a history of significant asthma attacks.

It's also important that a parent or guardian gives their permission for the child to take part, and the child (if old enough to understand) agrees as well. Children cannot join if they have certain other health conditions or are taking specific medications that might interfere with the study medicine.

If your child joins the study, it will involve several stages. First, there's a screening period of about 4 to 6 weeks to make sure your child is a good fit. After that, there's a main treatment period of 52 weeks (about a year).

During this year, your child will receive either Tezepelumab or a placebo by injections under the skin. Neither you nor the study team will know which one your child is receiving. There will be regular visits to the clinic for check-ups, breathing tests, and to make sure your child is doing well. After the 52-week treatment, there's a 12-week follow-up period.

There's also an optional extra part where all suitable children could receive Tezepelumab for another 104 weeks (about two years). In total, the study could last well over two years if your child takes part in the optional extension.