A Phase 2, Multicenter, Open-label Trial to Evaluate the Efficacy and Safety of Sibeprenlimab in Primary Membranous Nephropathy, Immune-mediated Focal Segmental Glomerulosclerosis, and Minimal Change Disease
Sponsor study identifier
interventional
20
0 countries
N/A
Study Start
December 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
June 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 30, 2026
Actual (reported)October 6, 2026
Actual (reported)December 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
pMN: Percentage of Participants With More Than (>) 80 Percent (%) Reduction From Baseline in Anti-Phospholipase A2 Receptor (PLA2R)
Week 25
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.
Week 25
pMN: Change From Baseline in Anti-PLA2R
Participants with primary membranous nephropathy (pMN) and immune-mediated focal segmental glomerulosclerosis (IM-FSGS) or minimal change disease (MCD) will receive a dose every four weeks for a total of seven doses.
SC injection
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First Submitted
September 30, 2026
First Posted
October 6, 2026
Study Start
December 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
June 15, 2028
EstimatedBaseline, Week 25
pMN, IM-FSGS, and MCD: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Up to Week 37
pMN, IM-FSGS, and MCD: Number of Participants With Clinically Significant Change in Laboratory Assessments From Baseline
Baseline, Week 37
pMN, IM-FSGS, and MCD: Number of Participants With Clinically Significant Change in Vital Sign Measurements From Baseline
Baseline, Week 37
pMN, IM-FSGS, and MCD: Number of Participants With Clinically Significant Change in Physical Examination Findings From Baseline
Baseline, Week 37
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 6, 2026
Record last verified: 2026-09
Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
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Source: ClinicalTrials.gov.
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