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

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

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 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 Type: Interventional (Clinical Trial)
Estimated Enrollment: 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blind (Participant, Care Provider and Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date: January 31, 2022
Estimated Primary Completion Date: October 30, 2025
Estimated Study Completion Date: February 2, 2027

Arm:
- Experimental: Anifrolumab
- Placebo Comparator: Placebo

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