Available in Spain, Colombia, Brazil, Argentina, Mexico, United States
This study aims to characterize the pharmacokinetics, pharmacodynamics, efficacy, and safety
of Anifrolumab solution for infusion compared with placebo solution for infusion in pediatric
participants with severe active systemic lupus erythematosus who are on background standard
of care therapy.
The study duration for a participant will be approximately 120 weeks, which includes:
- Screening period of up to 30 days.
- Part A consists of a four-week, double-blind, placebo-controlled, randomised,
pharmacokinetic period.
- Part B is a double-blind, placebo-controlled, randomised, safety/efficacy period lasting
48 weeks (for rollover participants from Part A) or 52 weeks (for de novo participants).
- Part C is a 52-week open-label extension period.
- Part D is a 12-week, safety follow-up period.
100Patients around the world