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

Systemic Lupus Erythematosus Clinical Trial

Official title: A Phase III, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of IV Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Moderate to Severe Active Systemic Lupus Erythematosus (SLE) While on Background Standard of Care Therapy

Status Recruiting

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. ;

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

• 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