Last updated 5 months ago

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

100 patients around the world
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.
AstraZeneca
100Patients around the world
This study is for people with
Lupus
Systemic lupus erythematosus
Requirements for the patient
To 17 Years
All Gender
Medical requirements
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