Baseline Characteristics in VISIONARY Trial of Sibeprenlimab

The phase 2 ENVISION study of sibeprenlimab revealed that the investigational drug significantly reduced proteinuria and stabilized estimated glomerular filtration rate (eGFR) among patients with immunoglobulin A nephropathy (IgAN). Sibeprenlimab is a humanized IgG2 monoclonal antibody that blocks the action of the B-cell growth factor APRIL (a proliferation-inducing ligand).

At the National Kidney Foundation Spring Clinical Meetings 2025, researchers presented baseline characteristics of patients in the phase 3 VISIONARY (NCT05248646) trial. VISIONARY, the largest phase 3 trial of an IgAN treatment to date, is intended to evaluate the efficacy and safety of sibeprenlimab. 

The ongoing, multicenter, double-blind, placebo-controlled study enrolled 510 patients from 5 continents who had IgAN and were at high risk for disease progression. Participants’ median age was 42 years, 58.8% were male, 59.0% were Asian, 36.7% were White, 0.8% were Black, and 3.5% were identified as “other” race. The mean (SD) systolic BP was 123.7 (11.7) mm Hg and mean (SD) diastolic BP was 78.5 (8.5) mm Hg. 

The mean (SD) 24-hour urine protein to creatinine ratio (UPCR) was 1.5 (0.9) g/g, and median 24-hour UPCR was 1.3 g/g. Of the total cohort, 402 (78.8%) patients had a screening 24-hour UPCR of 2.0 g/g or less, and 108 (21.2%) had a screening UPCR greater than 2.0 g/g. The mean (SD) 24-hour urine protein excretion was 2.1 (1.3) g/24 h. The median eGFR was 60.0 mL/min/1.73 m². Nearly all patients (97.8%) received renin-angiotensin system blockade therapy, and 45.1% received sodium-glucose cotransporter-2 inhibitors.

The study randomized patients with IgAN 1:1 to either receive sibeprenlimab 400 mg or subcutaneous placebo once every 4 weeks for a total of 26 doses. The primary end point is the relative change from baseline UPCR in 24-hour urine at month 9.

With a large, diverse study population, VISIONARY is expected to be broadly applicable to real-world clinical practice. Clinical results will be reported later in 2025.

Source: Perkovic V, Barratt J, Carroll K, et al. Patient baseline characteristics in the ongoing phase 3 VISIONARY trial: a randomized, placebo-controlled study of sibeprenlimab for immunoglobulin A nephropathy. Abstract #G-378. Presented at the National Kidney Foundation Spring Clinical Meetings 2025; April 10-13, 2025; Boston, MA. doi:10.1053/j.ajkd.2025.02.379. Funding for the study was provided by Otsuka Pharmaceutical Development & Commercialization, Inc.