Study identifier:D3461C00030
ClinicalTrials.gov identifier:NCT05835310
EudraCT identifier:N/A
CTIS identifier:2022-502289-25-00
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 (SLE) While on Background Standard of Care Therapy
Systemic Lupus Erythematosus
Phase 3
No
Placebo
All
100
Interventional
5 Years - 17 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Anifrolumab Randomized participants will receive a single dose of Anifrolumab via IV infusion every 4 weeks | Biological/Vaccine: Anifrolumab Participants will receive a single dose of Anifrolumab via IV infusion. Other Name: (MEDI-546) |
Placebo Comparator: Placebo Randomized participants will receive matching placebo via IV infusion | Drug: Placebo Participants will receive matching placebo via IV infusion |