BLOSSOM: A Study of Anifrolumab in Pediatric Participants with Systemic Lupus Erythematosus
Research type
Research Study
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
IRAS ID
1007583
Contact name
Assia Bensalem
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2022-502289-25
Clinicaltrials.gov Identifier
Research summary
The immune system usually defends the person against external agents, like infections, but when a person has a disease called Systemic Lupus Erythematosus (SLE), the immune system also attacks the person’s own body, causing damage to organs and several different symptoms. Anifrolumab is a medication that reduces the activation of the immune system, reducing in this way the SLE manifestations. Prior studies already proved that Anifrolumab is effective and safe in the treatment of adults with SLE, but the effects of this medication in children are not confirmed yet. This study is to verify how Anifrolumab will act in children, how the medication is distributed and eliminated. For that, about 100 children from 5 to less than 18 years old will join the study. The study will start with 8 children from 12 to less than 18 years old, with more than 40Kg, who will receive one infusion of the medication or placebo (an infusion with saline solution, without medication) and the distribution and elimination of the medication will be evaluated, to confirm if children should receive the same dose of adults, or if dose should be adjusted. These children will continue in the study to receive medication or placebo in monthly infusions through 48 weeks. After dose confirmation in this group, other group of 8 children from more than 5 and less than 18 years old, with less than 40Kg and more than 15Kg will receive the dose assigned to the previous group, to confirm if additional dose adequation is needed for the group with less than 40Kg. After dose of Anifrolumab is confirmed, additional patients will be recruited in both groups of age and weight, to receive medication or placebo in monthly infusions through 52 weeks, plus additional 52 weeks where all patients will receive Anifrolumab monthly.
REC name
London - Brent Research Ethics Committee
REC reference
24/LO/0405
Date of REC Opinion
1 Jul 2024
REC opinion
Further Information Favourable Opinion