Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)

Sponsor ID
417-201-00007
Clinicaltrials.gov ID
NCT05248646
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Active, Not Recruiting
Sponsor ID
417-201-00007
Trial Details
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Age
18+ years
Therapeutic Area
  • Autoimmune Disease
    • Sex
    Female & Male
    Trial Dates
    Mar 2022 - May 2026
    Healthy Volunteers
    No
    • Male and female patients ≥ 18 years of age .
    • Biopsy-confirmed IgAN. (Patients with an eGFR of 30 to 45 mL/min/1.73m2 must have had a kidney biopsy performed within 36 months of the screening visit).
    • Stable and maximally tolerated dose of ACEI and/or ARB for at least 3 months prior to screening. Patients who are on a stable dose of SGLT2i may participate if treatment was initiated ≥3 months prior to screening. Patients who are unable to take an ACEI or ARB may participate if their overall management conforms with standards of care and other protocol requirements.
    • Screening urine protein/creatinine ratio (uPCR) ≥ 0.75 g/g or urine protein ≥ 1.0 g/day
    • eGFR ≥ 30 mL/min/1.73 m2, (for the exploratory cohort only: eGFR 20- \<30 mL/min/1.73 m2), calculated using the 2021 CKD-EPI equation
    • Secondary forms of IgAN or IgA vasculitis.
    • Coexisting chronic kidney disease other than IgAN.
    • Kidney biopsy findings in addition to IgAN including those of diabetic nephropathy, membranous nephropathy, or lupus nephritis. Hypertensive vascular changes are acceptable.
    • Kidney biopsy MEST or MEST-C score of T2 or C2 (Oxford IgAN classification). If MEST-scoring was not performed, the presence of \> 50% tubulo-interstitial fibrosis, or crescents in \> 25% of glomeruli is exclusionary. This does not apply to the exploratory cohort.
    • Nephrotic syndrome
    • Serum IgG \< 600 mg/dL at screening.
    • Chronic systemic immunosuppression, including glucocorticoids, within 16 weeks of randomization
    • Participation in another interventional clinical trial and receipt of another investigational drug within 30 days prior to the administration of IMP or 5 half-lives from last investigational drug administration, whichever is longer.
    • Chronic infectious disease, or acute infectious disease at time of screening.
    • Type 1 diabetes, or poorly controlled Type 2 diabetes
    • Uncontrolled hypertension
    • The protocol provides additional information about these and other inclusion and exclusion criteria.

    Study Summary

    To Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Primary Immunoglobulin A Nephropathy

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: Sibeprenlimab 400 mg
    Type
    Interventional
    Masking
    Double
    Estimated Enrollment
    530
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • * Male and female patients ≥ 18 years of age .
    • * Biopsy-confirmed IgAN. (Patients with an eGFR of 30 to 45 mL/min/1.73m2 must have had a kidney biopsy performed within 36 months of the screening visit).

    Exclusion Criteria

    • * Secondary forms of IgAN or IgA vasculitis.
    • * Coexisting chronic kidney disease other than IgAN.
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Male and female patients ≥ 18 years of age .
    • Biopsy-confirmed IgAN. (Patients with an eGFR of 30 to 45 mL/min/1.73m2 must have had a kidney biopsy performed within 36 months of the screening visit).
    • Stable and maximally tolerated dose of ACEI and/or ARB for at least 3 months prior to screening. Patients who are on a stable dose of SGLT2i may participate if treatment was initiated ≥3 months prior to screening. Patients who are unable to take an ACEI or ARB may participate if their overall management conforms with standards of care and other protocol requirements.
    • Screening urine protein/creatinine ratio (uPCR) ≥ 0.75 g/g or urine protein ≥ 1.0 g/day
    • eGFR ≥ 30 mL/min/1.73 m2, (for the exploratory cohort only: eGFR 20- \<30 mL/min/1.73 m2), calculated using the 2021 CKD-EPI equation
    Exclusion Criteria:
    • Secondary forms of IgAN or IgA vasculitis.
    • Coexisting chronic kidney disease other than IgAN.
    • Kidney biopsy findings in addition to IgAN including those of diabetic nephropathy, membranous nephropathy, or lupus nephritis. Hypertensive vascular changes are acceptable.
    • Kidney biopsy MEST or MEST-C score of T2 or C2 (Oxford IgAN classification). If MEST-scoring was not performed, the presence of \> 50% tubulo-interstitial fibrosis, or crescents in \> 25% of glomeruli is exclusionary. This does not apply to the exploratory cohort.
    • Nephrotic syndrome
    • Serum IgG \< 600 mg/dL at screening.
    • Chronic systemic immunosuppression, including glucocorticoids, within 16 weeks of randomization
    • Participation in another interventional clinical trial and receipt of another investigational drug within 30 days prior to the administration of IMP or 5 half-lives from last investigational drug administration, whichever is longer.
    • Chronic infectious disease, or acute infectious disease at time of screening.
    • Type 1 diabetes, or poorly controlled Type 2 diabetes
    • Uncontrolled hypertension
    • The protocol provides additional information about these and other inclusion and exclusion criteria.

    Locations

    Location
    Status
    Location
    University of Alabama at Birmingham - Site #336
    Birmingham, Alabama, United States, 35233
    Status
    N/A
    Location
    Mayo Clinic Arizona - Site #363
    Phoenix, Arizona, United States, 85054
    Status
    N/A
    Location
    University of Arkansas for Medical Sciences - Site #353
    Little Rock, Arkansas, United States, 72205
    Status
    N/A
    Location
    Amicis Research Center - Site #341
    Granada Hills, California, United States, 91344
    Status
    N/A
    Location
    University of CA San Diego - Site #351
    La Jolla, California, United States, 92037
    Status
    N/A
    Location
    California Institute of Renal Research - Site #371
    La Mesa, California, United States, 91942
    Status
    N/A
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