Safety and Efficacy Study of VIS649 for IgA Nephropathy
Safety and Efficacy Study of VIS649 for IgA Nephropathy
Brief 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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Patient, Investigator, Care Provider, Outcomes Assessor
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: July 20, 2020
Estimated Primary Completion Date: November 15, 2022
Estimated Study Completion Date: December 1, 2022
Arm:
- Placebo Comparator: Placebo
- Experimental: Low Dose - VIS649
- Experimental: Medium Dose - VIS649
- Experimental: High Dose - VIS649
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 144 |
| Actual Study start date | 20 July 2020 |
| Estimated Study Completion Date | 01 December 2022 |