Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN)

Study Identifier:
417-201-00007
ClinicalTrials.gov Identifier:
NCT05248646
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Active, Not Recruiting
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Study Details

Medical Condition
  • Autoimmune Disease
Study Drug
  • Drug: Sibeprenlimab 400 mg
  • Drug: Placebo
Date
Mar 2022 - Dec 2026
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion 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 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.

Protocol Summary

This is a phase 3 study to evaluate effects on proteinuria and glomerular filtration rate of sibeprenlimab 400 mg subcutaneously (s.c.) Q 4 weeks in adults with IgAN who are receiving maximally tolerated standard-of-care therapy.

Study 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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July 2025 01US25EUC0279

Requirements information
Inclusion 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 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.

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