Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
BEYOND
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)
Breve descripción
The purpose of this study is to evaluate the safety and efficacy of BION-1301 in adults with IgA nephropathy.
Médico del ensayo / Coordinador del estudio
Carolina Cruz
Correo electrónicoNombre del sitio
Valiance Clinical Research
9844 Atlantic Ave, Suite B South Gate, CA 90280 USA
Patrocinador
Chinook Therapeutics
Fármaco del estudio
Zigakibart
Matrícula estimada
292
Fecha de finalización estimada
May 1, 2028
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
BEYOND
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)
Breve descripción
The purpose of this study is to evaluate the safety and efficacy of BION-1301 in adults with IgA nephropathy.
La prueba es para personas con
Primary immunoglobulin A nephropathy (IgAN) at risk of progressive loss of kidney function.
Objetivo del estudio
The goal of the BEYOND study is to evaluate the safety and efficacy of zigakibart in reducing proteinuria and slowing down kidney disease progression.
¿Qué implica para el paciente?
Patients will have assessments of safety and efficacy every 2 weeks over 2 years. Patients will also be followed up for safety for an additional 24 weeks after the last dose. Virtual trial options may include telemedicine, home health nurse visits and the option to self-administer at home (subject to local regulations and sponsor approval). Patients may be reimbursed for trial-related expenses.
Sobre el medicamento o la intervención
Zigakibart (BION-1301) is a novel, humanized monoclonal antibody that binds and blocks APRIL (A PRoliferation-Inducing Ligand).