Phase 2 Study of Weekly Subcutaneous ADX-097 in Adults 16 Years and Older with IgA Nephropathy, Lupus Nephritis, or C3 Glomerulopathy

What this Trial Is About

Researchers are conducting a Phase 2 study to evaluate the safety, pharmacodynamics, pharmacokinetics, and clinical activity of ADX-097 in male and female participants aged 16 years or older with Immunoglobulin A Nephropathy IgAN, Lupus Nephritis LN, or Complement Component 3 Glomerulopathy C3G. This study aims to better understand how ADX-097 works in these kidney-related conditions and to monitor its effects and safety profile. Participants will receive weekly subcutaneous injections of ADX-097. The study is open-label, meaning all participants receive the active drug without a placebo comparison. Treatment and observation will continue for up to 26 weeks, with regular dosing and monitoring throughout this period. During the study, participants will undergo various assessments including measurements of urine protein-to-creatinine ratio and estimated glomerular filtration rate to monitor kidney function. Blood samples will be taken at multiple time points to measure the concentration of ADX-097 in plasma. Safety will be closely monitored by recording any treatment-emergent adverse events over up to 30 weeks. The total participation duration may last until study completion in early 2028.

A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G