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

Sponsor ID
417-201-00009
Clinicaltrials.gov ID
NCT07770815
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
844-687-3522 or [email protected]
Will Be Recruiting
Sponsor ID
417-201-00009
Trial Details
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Age
2 - 17 Years
Therapeutic Area
  • Autoimmune/Kidney Disease
    • Sex
    Female & Male
    Trial Dates
    Sep 2026 - Dec 2029
    Healthy Volunteers
    No
    • 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.

    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).

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: Sibeprenlimab
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    24
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • 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.

    Exclusion Criteria

    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.

    Locations

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