Phase 2Not yet recruiting
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
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
- Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
- Enrolment
- 20 planned
- Conditions
- Primary Membranous Nephropathy; Minimal Change Disease; Focal Segmental Glomerulosclerosis
- Interventions
- Sibeprenlimab
- Ages
- adults, older adults
- Registry
- NCT07861113
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- 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
History
Study completion expected
Primary completion expected
Expected to start
Registered