An Efficacy and Safety Trial of Anifrolumab for Children with Lupus
Phase 3
100
about 5.8 years
5–17
22 sites in AZ, CA, DC +12
What this study is about
Researchers are testing whether intravenous anifrolumab, a treatment, is effective and safe in children with severe active lupus. The trial will last about 116 weeks and involves screening, a placebo-controlled period, and an open-label extension.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive Anifrolumab
- 2.Take Placebo
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
anifrolumab
Primary: Part A - Area under the serum concentration curve (AUC), Part A - Maximum observed serum (peak) drug concentration (Cmax)
Secondary: Part - B Change from baseline in anti-double stranded deoxyribonucleic acid antibodies, Part - B Change from baseline in complement component (C3), Part - B Change from baseline in complement component (C4), Part - B Change from baseline in total hemolytic complement (CH50), Part - B Change from baseline through Week 52 in antidrug antibody (ADA), Part B - Change from baseline through Week 52 in type I interferon (IFN) 21-gene signature
Immune