An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants

To join this study, a child or young person must be aged between 5 and 17 years old and have a diagnosis of Systemic Lupus Erythematosus (lupus) for at least three months. Their lupus needs to be considered 'moderate to severe' by their doctor. The child and their parent or guardian must be able to understand what the study involves and agree to take part.

There are also some important health checks. For example, participants must not have active tuberculosis (TB) or certain other serious infections like HIV or hepatitis B or C. They also can't have certain other conditions, like specific types of vasculitis (blood vessel inflammation) or other autoimmune diseases that involve a substance called interferon.

For girls and young women, specific rules about pregnancy testing and using contraception will apply throughout the study. Boys and young men will also need to use contraception. These rules are in place to ensure safety during the trial.

Taking part in this study means a commitment of approximately 116 weeks, which is just over two years. It starts with a screening period of up to 30 days to check if you meet all the requirements. After that, the study is divided into several parts.

For the first four weeks, some participants will receive Anifrolumab and others will get the placebo, without knowing which (this is called 'double-blind'). Then, for about 48 to 52 weeks, everyone continues with either the study drug or placebo. After this, all participants who wish to continue will receive Anifrolumab for another 52 weeks in an 'open-label' part, meaning everyone knows they are getting the active drug. Finally, there's a safety follow-up visit about 12 weeks after the last dose of the study medicine. Throughout the study, you'll have regular visits to the clinic for medical check-ups, blood tests, and to receive your study medication, which is given into a vein.