Atizapan De Zaragoza

Researchers are studying the pharmacokinetics, pharmacodynamics, efficacy, and safety of anifrolumab given by intravenous infusion compared with placebo in children aged 5 to under 18 years with moderate to severe active systemic lupus erythematosus (SLE) who are also receiving standard care treatments. This Phase III trial aims to better understand how anifrolumab works and its effects in this pediatric population. The study lasts about 116 weeks and includes several parts: a screening period of up to 30 days; Part A, a four-week double-blind, placebo-controlled, randomized phase focusing on pharmacokinetics; Part B, a double-blind, placebo-controlled, randomized safety and efficacy phase lasting 48 to 52 weeks depending on prior participation; Part C, a 52-week open-label extension where all participants receive anifrolumab; and Part D, a safety follow-up visit 12 weeks after the last dose. Participants will have regular evaluations including blood tests to measure drug levels and response, assessments of lupus activity, and monitoring for side effects. Key outcomes include drug concentration levels at various times and the number of participants responding to treatment at week 52. The study carefully tracks safety and effectiveness throughout all phases, with total participation lasting nearly two and a half years.