ANIFROLUMAB - IRIS STUDY
Anifrolumab is a human monoclonal antibody to the type I interferon (IFN) receptor subunit 1, which blocks the action of type I IFNs. Chronic activation of the type I interferon pathway plays a critical role in systemic lupus erythematosus pathogenesis. Two phase 3 studies (TULIP-1 and TULIP-2) and a phase 2b study (MUSE) provide substantial evidence for the efficacy and safety of anifrolumab for moderately to severely active SLE.
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How is Anifrolumab being studied in lupus nephritis?
The efficacy and safety of Anifrolumab in adult patients with Active Proliferative Lupus Nephritis is being evaluated in the IRIS study. 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 standard of care (consisting of MMF and glucocorticoids) in adults with active proliferative Class III or Class IV LN (both with or without concomitant Class V). The primary endpoint is the difference in proportion of participants with complete renal response in the anifrolumab group compared with placebo group.
Eligibility Criteria
Active proliferative LN Class III or IV either with or without the presence of Class V according to the 2003 ISN/RPS classification
Urine protein to creatinine ratio > 1 mg/mg (113.17 mg/mmol)
eGFR ≥ 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).
No signs of symptoms of active TB prior to or during screening or no treatment for latent TB