The Sub-Study 3 of A Phase 1b/2 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases (ES108001)

What this Trial Is About

Researchers are evaluating the investigational drug EVER001 for adults aged 18 to 75 years with selected proteinuric glomerular diseases: Focal Segmental Glomerulosclerosis (FSGS), Minimal Change Disease (MCD), and IgA Nephropathy (IgAN). This Phase 1b/2, open-label, multi-center study aims to assess the therapeutic potential and safety of EVER001, which affects multiple immune pathways without directly targeting T cells or depleting B cells. The study will be conducted at about 30 centers in China with 45 participants divided equally by disease type. Participants receive EVER001 as a 100 mg oral capsule taken twice daily at a dose of 200 mg (two capsules) for 52 weeks. This single-arm study evaluates the efficacy and safety of EVER001 in these kidney diseases. There are no placebo or comparator groups, and the treatment is administered orally under medical supervision throughout the study period. During the 52 weeks of treatment and up to Week 56, participants undergo various assessments including urine protein-to-creatinine ratio (UPCR), blood pressure, body weight, clinical laboratory safety tests, physical exams, chest X-rays, electrocardiograms, pulse rate, and body temperature measurements. Researchers will monitor treatment-emergent adverse events and other safety parameters. Additional evaluations include kidney function markers such as estimated glomerular filtration rate (eGFR) and serum albumin. The study aims to understand the drug's safety profile, pharmacokinetics, pharmacodynamics, and impact on disease measures over time.

Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases