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

NCT07614477 | Recruiting Phase 2

• 2 other identifiers: ES108001-001CTR20260886
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Minimal Change Disease (MCD); IgA Nephropathy (IgAN); Focal Segmental Glomerulosclerosis (FSGS)

Outcome Measures

Primary Outcomes (12)

• Percentage change from baseline in 24-hour urine protein-to-creatinine ratio (UPCR)

  Percentage change from baseline in 24-hour UPCR (based on 24-hour urine collection)

  Week24

• Treatment-emergent adverse events (TEAEs)

  Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs)

  Throughout the study period, up to Week 56

• Adverse events of special interest (AESIs)

  Incidence of adverse events of special interest (AESIs)

  Throughout the study period, up to Week 56

• Systolic blood pressure change from baseline

  Measured in mmHg using a calibrated clinical blood pressure monitor

  Throughout the study period, up to Week 56

• Body weight change from baseline

  Measured in kilograms (kg) using a calibrated clinical scale

  Throughout the study period, up to Week 56

• Change from baseline in clinical laboratory safety parameters

  Change from baseline in routine clinical laboratory safety parameters, measured using standard validated clinical laboratory assays and reported in standard clinical units

  Throughout the study period, up to Week 56

• Physical examination findings

  Incidence of new or worsening abnormalities in physical examination findings, assessed at scheduled study visits.

  Throughout the study period, up to Week 56

• Chest radiography findings

  Incidence of new or worsening abnormalities in chest radiography findings, assessed at scheduled study visits.

  Throughout the study period, up to Week 56

• 12-lead electrocardiogram (ECG) findings

  Incidence of new or worsening abnormalities in 12-lead electrocardiogram (ECG) findings, assessed at scheduled study visits.

  Throughout the study period, up to Week 56

• Pulse rate change from baseline

  Measured in beats per minute (bpm) using a calibrated vital signs monitor

  Throughout the study period, up to Week 56

• Diastolic blood pressure change from baseline

  Measured in mmHg using a calibrated clinical blood pressure monitor

  Throughout the study period, up to Week 56

• Body temperature change from baseline

  Measured in degrees Celsius (°C) using a calibrated clinical thermometer

  Throughout the study period, up to Week 56

Secondary Outcomes (20)

• Percentage change from baseline in 24-hour UPCR

  Week 2 and thereafter, up to Week 56

• Proportion of participants achieving complete remission (CR)

  Week 2 and thereafter, up to Week 56

• Proportion of IgAN participants with ≥30% reduction in 24-hour UPCR from baseline

  At Week 24, Week 36, and Week 52

• Change from baseline in estimated glomerular filtration rate (eGFR)

  Week 2 and thereafter, up to Week 56

• eGFR slope from baseline

  Baseline to Week 52

Study Arms (1)

EVER001 200mg bid

EXPERIMENTAL

Participants in this arm receive EVER001 200 mg administered twice daily (bid) orally. This single-arm cohort evaluates the efficacy and safety of EVER001 in subjects with FSGS, MCD, and IgA

Drug: EVER001

Interventions

EVER001 DRUG

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

EVER001 200mg bid

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary FSGS or MCD/IgAN confirmed by renal biopsy
• eGFR ≥ 45 mL/min/1.73 m²
• For participants with FSGS or MCD: must have a 24-hour urine protein-to-creatinine ratio (UPCR) \> 3.5 g/g and serum albumin \< 30 g/L during the screening period
• For participants in the IgAN group: 24-hour UPCR ≥ 0.8 g/g; ARB or ACEI stable for ≥ 12 weeks prior to Day 1
• Patients with FSGS or MCD who have not been treated with immunosuppressants or are sensitive to prior immunosuppressant treatment

You may not qualify if:

• Hereditary or secondary FSGS/MCD; collapsing FSGS
• BMI ≥ 35 kg/m² in participants with FSGS/MCD
• Evidence of diabetes mellitus or a history of diabetes mellitus
• Acute or chronic infection requiring treatment
• Patients infected with HIV, hepatitis C, syphilis, or hepatitis B
• Patients with current or prior inadequately treated active tuberculosis (TB), latent TB, or evidence of current household contact with active TB
• At risk of bleeding
• Baseline 24-hour UPCR \> 3 g/g and serum albumin \< 30 g/L in participants with IgAN

Sponsors & Collaborators

• Everest Medicines (China) Co.,Ltd.: lead

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, Hebei, China

RECRUITING

MeSH Terms

Conditions

Nephrosis, Lipoid; Glomerulonephritis, IGA; Glomerulosclerosis, Focal Segmental

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glomerulonephritis; Nephritis; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Fei Liao

CONTACT

+8621- 8012 5712; fei.liao@everestmedicines.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 29, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: May 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)