Phase II Study Shows Atacicept's Potential in Treating IgA Nephropathy
Introduction
IgA nephropathy (IgAN) is a common primary glomerulonephritis that can progress to kidney failure. Atacicept, a novel B-cell–targeted immunomodulator, has shown promise in reducing immunoglobulin levels in autoimmune diseases.
Methods
The JANUS study (NCT02808429) was a phase II, randomized, double-blind, placebo-controlled trial assessing atacicept's safety, pharmacodynamic effects, and efficacy in IgAN patients with proteinuria despite maximal standard care.
Results
Sixteen patients were randomized to placebo, atacicept 25 mg, or atacicept 75 mg weekly. Most treatment-emergent adverse events (TEAEs) were mild or moderate. Atacicept showed dose-dependent reductions in IgA, IgG, IgM, and Gd-IgA1 levels, with early proteinuria reduction observed at week 24. Renal function remained stable with atacicept but declined with placebo.
Conclusion
Atacicept demonstrated an acceptable safety profile and efficacy in reducing pathogenic factor Gd-IgA1 levels, suggesting potential benefits in proteinuria and renal function for IgAN patients. The study highlights the need for further investigation into atacicept's therapeutic potential in IgAN.