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.
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.
Have previously been diagnosed with IM-FSGS or MCD, confirmed by a kidney biopsy.
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.
Single group
Sibeprenlimab
DrugSC injection
pMN: Percentage of Participants With More Than (>) 80 Percent (%) Reduction From Baseline in Anti-Phospholipase A2 Receptor (PLA2R)
IM-FSGS and MCD: Percentage of Participants Remaining in Remission (Complete or Partial Remission) at Week 25
Complete or partial remission will be determined from the urinary protein/creatinine ratio \[uPCR\] and serum albumin measurements. The criteria for complete remission include uPCR less than \[\<\] 0.3 gram per gram \[g/g\] and normal serum albumin \> 3.5 grams per liter \[g/L\]). Criteria for partial remission include uPCR \< 1.0 g/g and normal serum albumin \> 3.5 g/L.
pMN: Change From Baseline in Anti-PLA2R
pMN, IM-FSGS, and MCD: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
pMN, IM-FSGS, and MCD: Number of Participants With Clinically Significant Change in Laboratory Assessments From Baseline
pMN, IM-FSGS, and MCD: Number of Participants With Clinically Significant Change in Vital Sign Measurements From Baseline
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