NCT04287985

Safety and Efficacy Study of VIS649 for IgA Nephropathy

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: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Visterra, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of VIS649 in participants with immunoglobulin A (IgA) Nephropathy (IgAN)

Detailed description

This is a Phase 2, double-blind, randomized, placebo-controlled study in patients aged 18 years and above with biopsy confirmed diagnosis of IgAN. The study is designed to test the safety and effectiveness of multiple doses of VIS649. The main objectives are to evaluate the safety and tolerability of VIS649 and to evaluate the dose response of different doses of VIS649 by measuring proteinuria. The study is comprised of three main periods, Screening, Treatment (12 months) and Follow-Up (4 months). Approximately 144 patients will be enrolled. The findings from this study will form the basis for subsequent clinical development of VIS649. VIS649 is a humanized immunoglobulin G (IgG2) monoclonal antibody that binds to and blocks the biological actions of the cytokine A PRoliferation Inducing Ligand (APRIL), a key factor in the production of aberrantly glycosylated IgA1 (a-g- IgA1), which is critical to the pathogenesis of IgAN.

Conditions

• Immunoglobulin A Nephropathy
• Glomerular Disease
• IgAN

Interventions

Type	Name	Description
DRUG	Dose-Placebo	Unit Dose Strength - 0.9%.
DRUG	Low Dose-VIS649	Dose Level = Low
DRUG	Medium Dose-VIS649	Dose Level = Medium
DRUG	High Dose-VIS649	Dose Level = High

Timeline

• Start date: 2020-07-20
• Primary completion: 2023-05-19
• Completion: 2023-06-18
• First posted: 2020-02-27
• Last updated: 2024-11-21
• Results posted: 2024-11-21

Locations

93 sites across 15 countries: United States, Australia, Canada, Hong Kong, India, Japan, Malaysia, Philippines, Singapore, South Korea, Spain, Sri Lanka, Taiwan, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study