Intervencionista
Un ensayo clínico en el que se usa un nuevo medicamento o dispositivo para medir un resultado específico.
APPEAR-C3G
Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy. (APPEAR-C3G)
Breve descripción
The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.
Médico del ensayo/Coordinador del estudio
Richard Lafayette
Correo electrónico Número de teléfono 650 723 6961Nombre del sitio
Stanford Univ School of Medicine
300 Pasteur Drive Suite A175 Stanford, California, 94305-5616
Nombre del patrocinador
Novartis Pharmaceuticals
Nombre del fármaco del estudio
LNP023/iptacopan
Matrícula estimada
68 patients globally
Fecha estimada de finalización
August 2023
Intervencionista
Un ensayo clínico en el que se usa un nuevo medicamento o dispositivo para medir un resultado específico.
APPEAR-C3G
Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy. (APPEAR-C3G)
Breve descripción
The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.
El ensayo es para personas con
C3 Glomerulopathy (C3G)
Objetivo del estudio
The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to placebo and standard of care in patients with native C3G.
Qué implica para el paciente?
Patients will be asked to attend a screening visit to assess eligibly. Medical history will be collected. The study team will collect biosamples (blood, urine, biopsy tissue). Visits may be in conjunction with normally scheduled appointments, but additional study visits may be required. If eligible, a patient will receive study medication or placebo on top of standard of care 6 months followed by active study medication for another 6 months and be routinely assessed for safety and efficacy.
Sobre el medicamento o la intervención
LNP023/iptacopan is an investigational drug that we are studying as a potential targeted treatment for people with C3G and other autoimmune diseases. The term "investigational" means that it is not currently approved for use by the general public. LNP023/iptacopan is thought to block a process in the body known to cause inflammation and kidney damage in people with C3G and other autoimmune diseases. The APPEAR-C3G trial will study the effects of LNP023/iptacopan on reducing inflammation and kidney damage in people with C3G.