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Trial of Sibeprenlimab in Children and Adolescents With Immunoglobulin A Nephropathy (IgAN)
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
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).
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
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-09-30
Completion Date
2030-02-23
Last Updated
2026-08-18
Healthy Volunteers
No
Conditions
Interventions
Sibeprenlimab
Sibeprenlimab is administered subcutaneously once every 4 weeks for 48 weeks at a weight-based dose
Standard of care
Standard of care therapy consists of angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs)