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Trial of Sibeprenlimab in Children and Adolescents With Immunoglobulin A Nephropathy (IgAN)

NCT07770815 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-08-18

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Sibeprenlimab

Sibeprenlimab is administered subcutaneously once every 4 weeks for 48 weeks at a weight-based dose

DRUG

Standard of care

Standard of care therapy consists of angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs)

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-12-29
Completion
2030-02-23
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07770815 on ClinicalTrials.gov