In a new study, researchers evaluated the treatment effects of BI655064, an anti-CD40 monoclonal antibody, as an add-on therapy for people living with lupus nephritis (LN, lupus related kidney disease). BI655064 is a humanized, antagonistic monoclonal antibody designed to block CD40-CD40L interaction, which is associated with disease activity and pathogenesis of lupus and other autoimmune diseases. 

As part of the phase II trial, 101 individuals with active LN underwent kidney biopsies and were randomized to receive BI655064 at doses of 120 mg, 180 mg, 240 mg or a placebo. Renal outcomes were assessed using estimated glomerular filtration rate (eGFR, measure of how well the kidneys are removing waste from the blood) and spot urine protein-to-urine creatinine ratio (UP/UC) at baseline, week 26, and week 52. Participants were categorized as “better” or “worse” based on clinical outcomes. 

The study found that in study participants with glomerular monocyte infiltration (a marker of immune activity in the kidneys), higher doses of BI655064 (180mg and 240mg) significantly improved proteinuria levels and increased the rate of complete renal response (CRR). Additionally, eGFR showed a trend toward improvement in these participants, further supporting the potential efficacy of BI655064 in targeting autoimmune-related kidney damage. 

While future studies are needed to validate the findings of this study, the results highlight the potential for utilizing biomarker-guided approaches to identify people living with LN who may benefit most from targeted therapies like BI655064. Learn more about lupus and the kidneys.

Read the study