Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 07 Aug 2026

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At a glance

07 Aug 2026 According to an Otsuka Pharmaceutical media release,
03 Aug 2026 Results presented at Otsuka Pharmaceutical media release.
27 Jul 2026 According to an Otsuka Pharmaceutical media release, data from this trial support Otsukas rolling submission of a supplemental Biologics License Application (sBLA) to the U.S. FDA for traditional approval of VOYXACT (sibeprenlimab-szsi). A complete analysis of the VISIONARY two-year eGFR results will be presented at an upcoming scientific congress.

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