Study identifier:D3461C00004
ClinicalTrials.gov identifier:NCT02446899
EudraCT identifier:N/A
CTIS identifier:N/A
A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus
Active Systemic Lupus Erythematosus
Phase 3
No
Placebo
All
373
Interventional
18 Years - 70 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Apr 2020 by AstraZeneca
AstraZeneca
PRA Health Sciences
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Anifrolumab Anifrolumab 300 mg intravenous infusion (IV) administered every 4 weeks for a total of 13 doses. | Biological/Vaccine: Anifrolumab Intravenous infusion (IV) |
Placebo Comparator: Placebo Placebo intravenous infusion (IV) administered every 4 weeks for a total of 13 doses. | Drug: Placebo Intravenous infusion (IV) |