About the “Blossom” Study
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of IV Anifrolumab compared with Placebo in Pediatric Participants 5 to < 18 Years of Age with Systemic Lupus Erythematosus while on background standard of care therapy.
We are doing this study to see if anifrolumab may be effective in treating children with SLE, and to see how well it is tolerated. This study will also measure levels of anifrolumab in the blood and learn more about the disease and associated health problems
Who Is This Study For?
What Should I Expect?
Screening Phase
Before you can start the anifrolumab or placebo you will undergo a series of tests. This is called screening. You will have one screening visit (if you weigh more than20 kg) or 2 screening visits (if you weigh 15 to ≤ 20 kg). Based on the results of the screening assessments, the study doctor will decide if you qualify to enter this study
Treatment Period
If you meet the screening criteria, you will be randomly assigned a study drug
(anifrolumab or placebo). You have a 3 in 4 chance of being given anifrolumab for the first year of the study (double-blind period). The placebo is a dummy substance with physical appearance identical to that of anifrolumab, but with no active ingredients. “Randomly assigned” means that whatever treatment you get will be by chance, like flipping a coin or drawing names out of a hat.
Open Label Period
During the second year (open label period) all participants will receive anifrolumab.
Follow Up Visit
For participants who qualify, they will have their information entered into a confidential database and be invited to participate in future visits.
Take the Online Screener to See if Your Child
May Qualify