Purpose of this Study
Participants will first complete screening tests. They will then be randomly assigned to receive either the study drug anifrolumab or a placebo during a 4 week treatment period. Researchers will compare how the body processes the drug and monitor safety while neither participants nor researchers know which treatment was given.
Who Can Participate?
Eligibility
Participants may be able to join if they are boys or girls ages 5 to 17 who have had systemic lupus erythematosus (SLE) for at least 6 months. They must have blood test results that confirm lupus and show the presence of certain lupus-related antibodies.
Age Range
5-17
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing anifrolumab in children and teens ages 5 to 17 with moderate to severe systemic lupus erythematosus (SLE). Researchers want to learn how the drug works in the body, how it affects the disease, how well it works, and how safe it is when used along with standard lupus treatments.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full 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 While on Background Standard of Care Therapy
Principal Investigator
Kaveh
Ardalan
Protocol Number
PRO00116736
NCT ID
NCT05835310
Phase
III
Enrollment Status
Open to Enrollment