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Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis — IRIS  

Lupus Nephritis Clinical Trial

Official title:
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

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05138133
Study type Interventional
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Status Recruiting
Phase Phase 3
Start date February 15, 2022
Completion date July 7, 2028
View Details
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