Adnkronos (Adnkronos) – Otsuka Pharmaceutical announced final two-year (24-month) results from the Phase 3 Visionary study, demonstrating sustained preservation of renal function with sibeprenlimab in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. Treatment with sibeprenlimab, according to a company statement, stabilized renal function and reduced the risk of a composite renal outcome defined by the occurrence of renal function decline or renal failure by 97,1% compared to placebo.
With the largest patient population ever evaluated over 2 years in a placebo-controlled study, Visionary provides a broad and robust body of evidence and is the first Phase 3 study in IgAN to achieve the Kdigo 2025 therapeutic goal of slowing the decline of renal function to near-physiological levels (eGFR decline <1 mL/min/1,73 m²/year for many adults). These results, it states, support selective inhibition of the APRIL protein as a disease-modifying therapeutic approach, targeting a major driver of IgAN pathogenesis. The data were presented at the American Society of Nephrology (ASN) Kidney Week 2026 in Denver, Colorado, in an oral presentation during the opening plenary session, a late-breaking poster presentation, and as part of the ASN press activities. The results were simultaneously published in The New England Journal of Medicine.
Among the 510 randomized patients – the note details – progression to the composite renal outcome occurred in 1 of 259 patients treated with sibeprenlimab (0,4%), compared with 28 of 251 patients treated with placebo (11,2%), corresponding to a 97,1% lower risk of a composite renal outcome.
Compared with placebo, fewer patients treated with sibeprenlimab experienced a persistent decline in eGFR of at least 40% (1 vs 28), a persistent doubling of serum creatinine (0 vs 13), or an eGFR persistently below 15 mL/min/1,73 m² (1 vs 10). No patients treated with sibeprenlimab initiated renal replacement therapy, compared with 5 patients in the placebo group.
Visionary had already met its primary endpoint, a reduction in 24-hour urinary protein-to-creatinine ratio (uPCR) at 9 months compared to baseline. The overall safety profile of sibeprenlimab remained consistent over the 2-year period, with similar rates of overall treatment-emergent adverse events (90,7% vs. 90,0%), infections and infestations (51,4% vs. 51,0%), and injection site reactions compared to placebo. No new safety signals emerged compared to previous analyses; furthermore, the rate of serious infections was lower with sibeprenlimab compared to placebo (1,9% vs. 4,0%), as were the rates of serious and severe adverse events and treatment discontinuations.
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