Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT05138133
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis
Detailed Description:
This Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study with OLE is to evaluate the efficacy and safety of anifrolumab versus placebo as added to SOC (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 142 weeks, including screening and follow-up. Double-blind period will be 76 weeks. Participants who complete double-blind treatment period may enter open-label extension to receive anifrolumab for up 52 weeks. Approximately 360 of the enrolled participants will be randomly assigned to study intervention (anifrolumab or placebo) at a ratio of 1:1 during double-blind treatment period.
Study:
NCT05138133
Study Brief:
Protocol Section:
NCT05138133