A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis

To join this study, children and babies need to be between 6 months and under 12 years old and weigh at least 9 kilograms. They must have been diagnosed with eczema that doctors consider moderate to severe, affecting at least 10% of their body. Also, their eczema shouldn't have responded well to standard steroid creams in the past six months. Their eczema must also meet certain scores for severity and itching.

There are some reasons why a child or baby might not be able to join. For example, they can't have used certain other eczema creams, medications (like some immune-suppressing drugs or strong steroids), or light therapy within a few weeks before starting the study. They also shouldn't have had a live vaccine recently, or have other skin conditions that might make it hard to tell if the treatment is working. If they have a serious infection needing treatment, they also can't take part.

If you decide to take part, your child will first go through a screening period of up to 4 weeks to check if they meet all the study requirements. For children aged 2 to under 12, they will then be randomly chosen to receive either Tralokinumab plus steroid cream, or a placebo (a dummy drug) plus steroid cream for the first 16 weeks. You, your child, and the study team won't know which treatment they're getting during this time (a "double-blind" approach). There's a 2 in 3 chance they'll get Tralokinumab during this initial period. After 16 weeks, all children will then receive Tralokinumab plus steroid cream for the rest of the treatment phase.

Babies aged 6 months to under 2 years will receive Tralokinumab plus steroid cream from the start, and everyone involved will know they are getting the active medicine. The study will involve regular visits, typically every two weeks for the first year, then every six weeks. Some of these check-ups might be done over the phone. The full study could last up to four years. After the treatment period ends, there will be a final 4-week follow-up to check on your child's safety.