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RECRUITING
NCT07614477
PHASE2

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

Sponsor: Everest Medicines (China) Co.,Ltd.

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-05-15

Completion Date

2029-03-31

Last Updated

2026-05-29

Healthy Volunteers

No

Interventions

DRUG

EVER001

EVER001 200 mg, oral administration, twice daily (bid), for the treatment of proteinuric glomerular diseases including FSGS , MCD , and IgA

Locations (2)

Peking University First Hospital

Beijing, Beijing Municipality, China

Tianjin Medical University General Hospital

Tianjin, Hebei, China