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

Study Identifier:
417-201-00009
ClinicalTrials.gov Identifier:
NCT07770815
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
844-687-3522 or [email protected]
Will Be Recruiting
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Study Details

Medical Condition
  • Autoimmune/Kidney Disease
Study Drug
  • Drug: Sibeprenlimab
  • Drug: Standard of care
Date
Sep 2026 - Dec 2029
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 2 - 17 Years
Requirements Information
Inclusion and Exclusion Criteria
  • Source-verified, biopsy-confirmed IgA nephropathy (IgAN).
  • 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.
  • 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.
  • 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).
  • Estimated glomerular filtration rate (eGFR) ≥ 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2).
  • No evidence of coexisting chronic kidney disease other than IgAN.
  • Serum immunoglobulin G (IgG) ≥ 600 mg/dL at screening.
  • Kidney biopsy findings not demonstrating additional pathological features inconsistent with IgAN.

Protocol 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).

Study Locations

No locations found.
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July 2025 01US25EUC0279

Requirements information
  • Source-verified, biopsy-confirmed IgA nephropathy (IgAN).
  • 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.
  • 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.
  • 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).
  • Estimated glomerular filtration rate (eGFR) ≥ 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2).
  • No evidence of coexisting chronic kidney disease other than IgAN.
  • Serum immunoglobulin G (IgG) ≥ 600 mg/dL at screening.
  • Kidney biopsy findings not demonstrating additional pathological features inconsistent with IgAN.

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