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

NCT07770815 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 417-201-00009
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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).

Conditions

IgA Nephropathy

Outcome Measures

Primary Outcomes (3)

• Ratio of Urine Protein-to-Creatinine Ratio (uPCR) at Week 40 Compared With Baseline Using First-void Spot Urine Samples

  Baseline, Week 40

• Serum Concentration of Sibeprenlimab Through Week 52

  Baseline through Week 52

• Change From Baseline in Serum Immunoglobulin A (IgA) Through Week 52

  Baseline through Week 52

Secondary Outcomes (6)

• Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Study Discontinuations Due to Adverse Events Through Week 60

  Baseline through Week 60

• Number of Participants With Clinically Significant Changes in Vital Signs Through Week 60

  Baseline through Week 60

• Number of Participants With Clinically Significant Changes in Physical Examination Findings Through Week 60

  Baseline through Week 60

• Number of Participants With Clinically Significant Changes in Laboratory Assessments Through Week 60

  Baseline through Week 60

• Number of Injection Site Reactions Through Week 52

  Baseline through Week 52

Study Arms (1)

Sibeprenlimab

EXPERIMENTAL

Sibeprenlimab is administered subcutaneously once every 4 weeks for 48 weeks as an add-on to standard of care treatment at a weight-based dose.

Drug: Sibeprenlimab; Drug: Standard of care

Interventions

Sibeprenlimab DRUG

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

Sibeprenlimab

Standard of care DRUG

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

Sibeprenlimab

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

1. Source-verified, biopsy-confirmed IgA nephropathy (IgAN). 2. Receiving a stable and maximally tolerated dose of authorized angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs) for at least 12 weeks. 3. Participants receiving a stable dose of sodium-glucose cotransporter-2 inhibitor (SGLT2i) therapy for IgAN, if available, in addition to ACEIs and/or ARBs, must have initiated SGLT2i treatment for at least 12 weeks. 4. Participants must have a urine protein/creatinine ratio (uPCR) ≥ 0.75 grams per gram (g/g), as measured from the geometric mean of 3 first void spot urine samples (collected within the screening window prior to Dose 1). 5. Estimated glomerular filtration rate (eGFR) ≥ 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2). 6. No evidence of coexisting chronic kidney disease other than IgAN. 7. Serum immunoglobulin G (IgG) ≥ 600 mg/dL at screening. 8. Kidney biopsy findings not demonstrating additional pathological features inconsistent with IgAN.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Related Links

• Otsuka Clinical Trials Website
• Otsuka Clinical Trial Transparency

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Otsuka Call Center

CONTACT

844-687-3522; Otsuka-ProfessionalServices@otsuka-us.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 18, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): December 29, 2029
• Study Completion (Estimated): February 23, 2030
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/