drugset / Trial / NCT07614477

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

NCT07614477 ↗

Phase 2 Recruiting 45 enrolled Everest Medicines (China) Co.,Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 1b/2, open-label, multi-center study evaluating the therapeutic potential and safety of the investigational drug EVER001 in adults with FSGS, MCD, or IgAN. EVER001 acts on multiple immune pathways without directly affecting T cells or depleting B cells (both are lymphocytes). The study will be conducted at \~30 centers in China, enrolling 45 participants aged 18-75 years (15 per indication). The IMP is a 100 mg oral capsule, dosed at 200 mg twice daily (2 capsules per dose, 4 daily) for 52 weeks.

Timeline

Start
2026-05-15
Primary completion
2028-12-31
Completion
2029-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject EVER001 Unknown 200 mg Oral