A Multicenter, Open-Label, Phase II Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age with Systemic Lupus Erythematosus.
Saphnelo 120 mg solution for injection in pre-filled syringe
Eligibility
Age group
0-17 years
Sex
Female, Male
Primary endpoint
PK parameters of Cmax, AUC, tmax, and CL/F (all following the first dose), and Ctrough,ss (at Week 12), as data allow
Endpoint detail
Suppression of type I IFN 21-gene signature at Week 12 and 52. Change from baseline at Week 12 and 52 in: - Anti-dsDNA antibodies - C3, C4, and CH50 complement levels, Incidence of ADAs against anifrolumab
Official registry record
This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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