clinical trial · NCT07770815
Trial of Sibeprenlimab in Children and Adolescents With Immunoglobulin A Nephropathy (IgAN)
Otsuka Pharmaceutical Development & Commercialization, Inc.·phase3·not yet recruiting·n = 24
IgA NephropathySibeprenlimabStandard of care
brief summary
This Phase 3, open-label study will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of sibeprenlimab administered subcutaneously every 4 weeks in pediatric participants aged 2 to 17 years with IgA nephropathy (IgAN). Sibeprenlimab will be administered as an add-on to standard of care therapy consisting of angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs).
started
Sep 30, 2026
primary completion
Dec 29, 2029
completion
Feb 23, 2030
last updated
Aug 18, 2026
official title
A Phase 3, Open-label, Single-arm, Repeat-dose Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Sibeprenlimab Administered Subcutaneously in Children and Adolescents With Immunoglobulin A Nephropathy
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol