A Study to Assess Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis

This study is for children between 2 and 11 years old. To be considered, your child needs to have a specific weight (at least 10 kg) and their height and weight should be typical for their age according to growth charts. They must have had eczema symptoms for at least 6 months before starting the study.

Their eczema also needs to be classed as moderate to severe by the doctors. This means specific scores on eczema assessments, affecting at least 10% of their body, and they must be experiencing significant daily itching (with a score of 4 or higher out of 10). They will also need to have tried other treatments like creams or injections in the past that haven't worked well enough, or for whom these treatments aren't suitable.

There are also specific requirements about previous treatments your child may have had. For instance, if they've received strong oral steroids, there are conditions around that. The study aims to include children for whom a strong treatment like upadacitinib or dupilumab is a suitable next step.

If your child joins this study, they will either receive upadacitinib tablets once a day (or a liquid form twice a day) for about 3 years, or dupilumab injections every 2 or 4 weeks for about a year. After either treatment period, your child will be carefully monitored: for 30 days after their last upadacitinib dose, and for at least 12 weeks after their last dupilumab dose.

Taking part will mean a number of visits to a hospital or clinic. These visits will be regular, and the care your child receives will be more involved than their usual doctor's appointments. During these visits, doctors and nurses will assess your child's eczema, take blood tests, check for possible side effects, and ask you to complete questionnaires about your child's health and how they are feeling.