The Discovery Trial for IgAN, MN, LN, and C3G Patients
A Phase 2 Study to Evaluate the Safety and Biologic Activity of APL- 2 in Patients With IgA Nephropathy, Lupus Nephritis, Primary Membranous Nephropathy, or C3 Glomerulopathy (C3 Glomerulonephritis and Dense Deposit Disease)
Breve descripción
This is a Phase II trial assessing the safety and preliminary efficacy of daily APL-2 subcutaneous infusion administered for 16 weeks with a 6 month safety follow up, in patients with glomerulopathies
Médico del ensayo/Coordinador del estudio
Federico Grossi, MD, PhD
Correo electrónico Número de teléfono 617-977-5715Nombre del sitio
Apellis Investigational Site
Nombre del patrocinador
Apellis Pharmaceuticals, Inc.
Nombre del fármaco del estudio
APL-2
Matrícula estimada
48
Fecha estimada de finalización
October, 2019
The Discovery Trial for IgAN, MN, LN, and C3G Patients
A Phase 2 Study to Evaluate the Safety and Biologic Activity of APL- 2 in Patients With IgA Nephropathy, Lupus Nephritis, Primary Membranous Nephropathy, or C3 Glomerulopathy (C3 Glomerulonephritis and Dense Deposit Disease)
Breve descripción
This is a Phase II trial assessing the safety and preliminary efficacy of daily APL-2 subcutaneous infusion administered for 16 weeks with a 6 month safety follow up, in patients with glomerulopathies
El ensayo es para personas con
Primary Membranous Nephropathy (MN), IgA Nephropathy (IgAN), C3 Glomerulopathy (C3G)
Objetivo del estudio
To determine if APL-2 can cause a reduction of proteinuria in patients with IgAN, C3G, or MN.
Qué implica para el paciente?
Patients will be involved in the study for 16 weeks, and will take the study drug as a daily subcutaneous injection.
Sobre el medicamento o la intervención
APL-2 is a C3 complement mediator administered as daily subcutaneous infusions.