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

Study Identifier:

417-201-00132

ClinicalTrials.gov Identifier:

NCT07861113

EudraCT Identifier:

N/A

EU CT ID:

N/A

Study Contact Information:

844-687-8522 or [email protected]

Will Be Recruiting

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Study Details

Medical Condition

Primary Membranous Nephropathy (PMN)
Minimal Change Disease (MCD)
Focal Segmental Glomerulosclerosis (FSGS)

Study Drug

Drug: Sibeprenlimab

Date

Dec 2026 - Jun 2028

Phase 1/2

Phase 2/3

Phase 1

Phase 2

Phase 3

Phase 4

N/A

Patient Requirements

Sex: Female & Male

Age: 18 - 75 Years

Requirements Information

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.

Protocol 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.

Study Locations

No locations found.

July 2025 01US25EUC0279

Requirements information

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.

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

Study Details

Protocol Summary

Study Locations

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July 2025 01US25EUC0279