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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy and Safety of VIS649 in Participants With Immunoglobulin A (IgA) Nephropathy

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Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy and Safety of VIS649 in Participants With Immunoglobulin A (IgA) Nephropathy

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 29 May 2025

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At a glance

  • Drugs Sibeprenlimab (Primary)
  • Indications IgA nephropathy
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ENVISION
  • Sponsors Visterra

Most Recent Events

  • 27 May 2025 According to an Otsuka Pharmaceutical Media Release, the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sibeprenlimab in adults with immunoglobulin A nephropathy (IgAN). The FDA target action date (PDUFA date) is set for November 28, 2025.
  • 31 Mar 2025 According to an Otsuka Pharmaceutical Media Release, The BLA submission, Otsuka's first, is supported by results from the Phase 2 ENVISION clinical trial (NCT04287985) and the Phase 3 VISIONARY clinical trial (NCT05248646).
  • 22 Oct 2024 According to an Otsuka Pharmaceutical Media Release, Sibeprenlimab Receives U.S. FDA Breakthrough Therapy Designation for the Treatment of Immunoglobulin A Nephropathy, following favorable results of the Phase 2 ENVISION clinical trial.

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