Study identifier:D3468C00003
ClinicalTrials.gov identifier:NCT04931563
EudraCT identifier:N/A
CTIS identifier:N/A
A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Anifrolumab in Asian Participants with Active Systemic Lupus Erythematosus
Active Systemic Lupus Erythematosus
Phase 3
No
placebo
All
276
Interventional
18 Years - 70 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jul 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Placebo Comparator: placebo Placebo will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart. | Drug: placebo Intravenous infusion (IV) |
Active Comparator: anifrolumab Anifrolumab will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart. | Biological/Vaccine: Anifrolumab Intravenous infusion (IV) |