Intervencionista
Un ensayo clínico en el que se usa un nuevo medicamento o dispositivo para medir un resultado específico.
Visionary
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy (IgAN)
Breve descripción
This phase 3 trial will assess the efficacy and safety of sibeprenlimab administered SC once every 4 weeks as an add-on to standard of care (SOC) treatment (eg, angiotensin-converting enzyme inhibitors [ACEIs] and/or angiotensin receptor blockers [ARBs]). Furthermore, subjects who are on a stable dose of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy for IgAN, in addition to ACEIs and/or ARBs, may participate in the trial if treatment was initiated at least 3 months prior to
screening.
Médico del ensayo/Coordinador del estudio
Erika Jodice
Correo electrónicoNombre del sitio
Georgia Nephrology Research Institute
575 Professional Drive suite 250, Lawrenceville, GA, USA
Nombre del patrocinador
Otsuka Pharmaceutical Development & Commercialization, Inc.
Nombre del fármaco del estudio
Sibeprenlimab
Matrícula estimada
470
Fecha estimada de finalización
2026
Intervencionista
Un ensayo clínico en el que se usa un nuevo medicamento o dispositivo para medir un resultado específico.
Visionary
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy (IgAN)
Breve descripción
This phase 3 trial will assess the efficacy and safety of sibeprenlimab administered SC once every 4 weeks as an add-on to standard of care (SOC) treatment (eg, angiotensin-converting enzyme inhibitors [ACEIs] and/or angiotensin receptor blockers [ARBs]). Furthermore, subjects who are on a stable dose of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy for IgAN, in addition to ACEIs and/or ARBs, may participate in the trial if treatment was initiated at least 3 months prior to
screening.
El ensayo es para personas con
Immunoglobulin A Nephropathy
Objetivo del estudio
Sibeprenlimab is being developed for the treatment of immunoglobin A nephropathy (IgAN), a chronic disease affecting the kidneys which is characterized clinically by proteinuria, hematuria, and progressive decline of glomerular filtration rate and histologically by deposition of Immunoglobulin A (IgA) in the kidney. This phase 3 trial will assess the efficacy and safety of sibeprenlimab administered SC once every 4 weeks as an add-on to standard of care (SOC) treatment.
Qué implica para el paciente?
Subjects will be evaluated throughout the trial for safety, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity assessments. The total trial duration for each subject will be approximately 121 weeks (assuming up to60 days [approximately 9 weeks] for screening, 26 doses administered once every4 weeks from Day 1 to Week 100, a follow-up visit in Week 104, and ending with an end-of-trial visit in Week 112).
Sobre el medicamento o la intervención
Sibeprenlimab (VIS649) is a humanized IgG2 monocolonal antibody directed against the functionally conserved receptor binding domain of APRIL, blocking binding to its receptors, TACI, and BCMA.