A Study to Evaluate the Effectiveness and Safety of Sibeprenlimab in Participants With Primary Membranous Nephropathy, Immune‑mediated Focal Segmental Glomerulosclerosis, and Minimal Change Disease

Sponsor ID
417-201-00132
Clinicaltrials.gov ID
NCT07861113
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
844-687-8522 or [email protected]
Will Be Recruiting
Sponsor ID
417-201-00132
Trial Details
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Age
18 - 75 Years
Therapeutic Area
  • Unmapped
    • Sex
    Female & Male
    Trial Dates
    Dec 2026 - Jun 2028
    Healthy Volunteers
    No
    • For people with pMN:
    • Be experiencing their first episode of pMN, or have pMN that has returned after getting better (relapsed), with ongoing signs of significant kidney disease based on urine and blood tests.
    • Have a blood test showing high levels of antibodies against PLA2R, a protein linked to pMN, and these antibody levels must not have improved significantly over the previous 8 to 24 weeks.
    • Be taking a stable, maximum tolerated dose of a kidney-protective medication (such as an angiotensin converting enzyme (ACE) inhibitor or angiotensin II receptor blockers \[ARB\]) for at least 3 months before screening. Other medications that help reduce protein in the urine may also be allowed if the dose has remained unchanged for at least 3 months.
    • For people with IM-FSGS or MCD:
    • Have previously been diagnosed with IM-FSGS or MCD, confirmed by a kidney biopsy.
    • Currently have their disease well controlled, either in complete remission or partial remission, based on urine and blood test results.
    • Have a disease that depends on immunosuppressive treatment (medications that reduce immune system activity), meaning:
    • They need ongoing treatment with medications such as steroids or calcineurin inhibitors (CNIs) to keep the disease under control; and
    • Within the last 18 months, they experienced a return of nephrotic syndrome (severe kidney disease symptoms) shortly after reducing or stopping immunosuppressive treatment.
    • Be taking a stable dose of steroids or CNIs for at least 4 weeks before screening.
    • Have a kidney condition other than pMN, IM-FSGS or MCD, or have previously received a kidney transplant.
    • Have another serious autoimmune disease that could affect their health or study results.
    • Have a serious active infection, such as human immunodeficiency virus (HIV), hepatitis B, hepatitis C, tuberculosis (TB), or other significant chronic infections.
    • Have uncontrolled high or low blood pressure.
    • Have a serious medical condition, including certain cancers, that could make study participation unsafe.
    • Have Type 1 diabetes or poorly controlled Type 2 diabetes.
    • Have recently received certain immune-suppressing treatments or other medications that could interfere with the study.
    • Are currently participating in another clinical trial or have recently received an investigational medicine.
    • Have a history of a severe allergic reaction to ingredients in the study drug.
    • Have recent alcohol or substance abuse that could interfere with participation.
    • Are unable to follow study procedures or attend required study visits.
    • Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

    Study Summary

    This study will assess whether sibeprenlimab can help improve kidney disease in adults with primary membranous nephropathy (pMN) by reducing harmful antibodies linked to the disease. The study will also assess whether sibeprenlimab can help adults with immune-mediated focal segmental glomerulosclerosis (IM-FSGS) or minimal change disease (MCD) stay in remission and prevent their kidney disease from returning.

    Additional Study Details

    Phase
    Phase 2
    Study Drug
    Drug: Sibeprenlimab
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    20
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • For people with pMN:
    • 1. Be experiencing their first episode of pMN, or have pMN that has returned after getting better (relapsed), with ongoing signs of significant kidney disease based on urine and blood tests.

    Exclusion Criteria

    • 1. Have a kidney condition other than pMN, IM-FSGS or MCD, or have previously received a kidney transplant.
    • 2. Have another serious autoimmune disease that could affect their health or study results.
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • For people with pMN:
    • Be experiencing their first episode of pMN, or have pMN that has returned after getting better (relapsed), with ongoing signs of significant kidney disease based on urine and blood tests.
    • Have a blood test showing high levels of antibodies against PLA2R, a protein linked to pMN, and these antibody levels must not have improved significantly over the previous 8 to 24 weeks.
    • Be taking a stable, maximum tolerated dose of a kidney-protective medication (such as an angiotensin converting enzyme (ACE) inhibitor or angiotensin II receptor blockers \[ARB\]) for at least 3 months before screening. Other medications that help reduce protein in the urine may also be allowed if the dose has remained unchanged for at least 3 months.
    • For people with IM-FSGS or MCD:
    • Have previously been diagnosed with IM-FSGS or MCD, confirmed by a kidney biopsy.
    • Currently have their disease well controlled, either in complete remission or partial remission, based on urine and blood test results.
    • Have a disease that depends on immunosuppressive treatment (medications that reduce immune system activity), meaning:
    • They need ongoing treatment with medications such as steroids or calcineurin inhibitors (CNIs) to keep the disease under control; and
    • Within the last 18 months, they experienced a return of nephrotic syndrome (severe kidney disease symptoms) shortly after reducing or stopping immunosuppressive treatment.
    • Be taking a stable dose of steroids or CNIs for at least 4 weeks before screening.
    Exclusion Criteria:
    • Have a kidney condition other than pMN, IM-FSGS or MCD, or have previously received a kidney transplant.
    • Have another serious autoimmune disease that could affect their health or study results.
    • Have a serious active infection, such as human immunodeficiency virus (HIV), hepatitis B, hepatitis C, tuberculosis (TB), or other significant chronic infections.
    • Have uncontrolled high or low blood pressure.
    • Have a serious medical condition, including certain cancers, that could make study participation unsafe.
    • Have Type 1 diabetes or poorly controlled Type 2 diabetes.
    • Have recently received certain immune-suppressing treatments or other medications that could interfere with the study.
    • Are currently participating in another clinical trial or have recently received an investigational medicine.
    • Have a history of a severe allergic reaction to ingredients in the study drug.
    • Have recent alcohol or substance abuse that could interfere with participation.
    • Are unable to follow study procedures or attend required study visits.
    • Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

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