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Clinical Trial Summary

A Study to evaluate the PK, PD, efficacy, and safety of Anifrolumab in children with moderate to severe active SLE


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05835310
Study type Interventional
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Status Recruiting
Phase Phase 3
Start date March 14, 2024
Completion date January 15, 2030

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