Study identifier:D3466C00001
ClinicalTrials.gov identifier:NCT05138133
EudraCT identifier:2021-002862-42
CTIS identifier:2023-506359-68-00
A Multicentre Randomized Double-Blind Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients with Active Proliferative Lupus Nephritis
Lupus Nephritis
Phase 3
No
Anifrolumab, Placebo
All
360
Interventional
18 Years - 70 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jul 2025 by AstraZeneca
AstraZeneca
-
The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis
This is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of anifrolumab versus placebo as added to SOC (consisting of MMF and glucocorticoids) in adults with active proliferative Class III or Class IV LN (both with or without concomitant Class V). The total study duration may be up to approximately 116 weeks, including the Screening and Follow-up. Approximately 360 participants will be randomized in a 1:1 ratio to receive anifrolumab or matching placebo throughout during the Treatment Period.
Location
Status
Location
Düsseldorf, Germany, 40225
Status
Recruiting
Location
Muang, Thailand, 50200
Status
Recruiting
Location
Hat Yai, Thailand, 90110
Status
Recruiting
Location
Bangkok, Thailand, 10220
Status
Recruiting
Location
Ratchathewi, Thailand, 10400
Status
Recruiting
Location
Bangkok, Thailand, 10330
Status
Recruiting
Location
Mainz am Rhein, Germany, 55131
Status
Recruiting
Location
Kirchheim, Germany, 73230
Status
Recruiting
Arms | Assigned Interventions |
---|---|
Experimental: Anifrolumab Solution for intravenous infusion | Drug: Anifrolumab Anifrolumab intravenous infusion (IV) Other Name: Medi-546 |
Placebo Comparator: Placebo Solution for intravenous infusion | Drug: Placebo Placebo intravenous infusion (IV) |
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