Phase III Study of Intravenous Anifrolumab in Children 5 to 17 Years Old With Moderate to Severe Active Systemic Lupus Erythematosus on Standard Therapy

What this Trial Is About

Researchers are evaluating the pharmacokinetics, pharmacodynamics, efficacy, and safety of intravenous anifrolumab compared with placebo in children aged 5 to under 18 years with moderate to severe active systemic lupus erythematosus SLE who are receiving standard care. This phase III clinical trial aims to better understand how anifrolumab works and its effects in this pediatric population. Participants are randomly assigned to receive either anifrolumab or matching placebo via intravenous infusion every 4 weeks. The study includes several periods Part A is a 4-week double-blind pharmacokinetic phase Part B is a 48- to 52-week double-blind safety and efficacy phase Part C is a 52-week open-label extension and Part D involves a safety follow-up visit 12 weeks after the last dose. During the approximately 116-week study, participants undergo screening for up to 30 days, followed by regular infusions and assessments including blood tests to measure drug levels and immune markers. Researchers evaluate responses using disease activity scores and track safety throughout. The study concludes with a safety follow-up visit to monitor participants after completing treatment.

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