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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: IgA Nephropathy (IgAN); Focal Segmental Glomerulosclerosis (FSGS); Minimal Change Disease (MCD)
• Intervention / Treatment: Drug: EVER001

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Fei Liao; Phone Number: +8621- 8012 5712; Email: fei.liao@everestmedicines.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Recruiting
      • Peking University First Hospital
      • Contact: Hong Zhang; Phone Number: +8610-83575530; Email: hongzh@bjmu.edu.cn
  • Hebei
    • Tianjin, Hebei, China
      • Recruiting
      • Tianjin Medical University General Hospital
      • Contact: yan jun Jia; Phone Number: +86-13821735536; Email: jiajunya@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EVER001 200mg bid; 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; EVER001 200 mg, oral administration, twice daily (bid), for the treatment of proteinuric glomerular diseases including FSGS , MCD , and IgA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change from baseline in 24-hour UPCR	Percentage change from baseline in 24-hour urine protein-to-creatinine ratio (UPCR)	Week 2 and thereafter, up to Week 56
Proportion of participants achieving complete remission (CR)	Proportion of participants achieving complete remission (CR) based on predefined criteria	Week 2 and thereafter, up to Week 56
Proportion of IgAN participants with ≥30% reduction in 24-hour UPCR from baseline	Proportion of participants with IgAN achieving ≥30% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) from baseline, assessed at Week 24, Week 36, and Week 52	At Week 24, Week 36, and Week 52
Change from baseline in estimated glomerular filtration rate (eGFR)	Absolute and percentage change from baseline in estimated glomerular filtration rate (eGFR), calculated per the formula specified in the study protocol	Week 2 and thereafter, up to Week 56
eGFR slope from baseline	Slope of change in estimated glomerular filtration rate (eGFR, calculated per the formula specified in the study protocol) from baseline to Week 52	Baseline to Week 52
Percentage change from baseline in serum albumin	Percentage change from baseline in serum albumin level	Week 2 and thereafter, up to Week 56
Proportion of participants achieving partial remission (PR)	Proportion of participants achieving partial remission (PR) based on predefined study criteria	Week 2 and thereafter, up to Week 56
Proportion of participants achieving CR or PR	Proportion of participants achieving complete remission (CR) or partial remission (PR) based on predefined study criteria	Week 2 and thereafter, up to Week 56
Time to achieve CR or PR	Time from baseline to first documented complete remission (CR) or partial remission (PR), based on predefined study criteria	Baseline to Week 52
Proportion of participants with relapse (CR/PR, no rescue therapy)	Proportion of participants who experience relapse among those achieving CR or PR during the study and not receiving rescue therapy	From Day1 to Week 52
Time from CR/PR to relapse	Time from first documented complete remission (CR) or partial remission (PR) to first documented relapse	From Day1 to Week 52
Cumulative dose of glucocorticoids (GC)	Cumulative dose of glucocorticoids (GC), measured in prednisone equivalent dose, calculated at the specified study visits	Week 16, Week 24, Week 32, Week 40, and Week 52
Proportion requiring GC increase or additional immunosuppressants	Proportion of participants requiring increase in GC dosage and/or initiation of additional immunosuppressants	Throughout the study period (baseline to Week 56)
Proportion of IgAN participants with positive hematuria	Proportion of participants with IgAN with positive hematuria	At baseline, Week 12, Week 24, Week 36, and Week 52
Resolution of hematuria in IgAN participants	Resolution of hematuria in participants with IgA	At Week 12, Week 24, Week 36, and Week 52
Change from baseline in BTK target occupancy	Change from baseline in BTK target occupancy in peripheral blood cells	Throughout the study period, up to Week 56
Plasma EVER001 peak concentration (Cmax)	Plasma EVER001 peak concentration (Cmax)	Throughout the study period, up to Week 56
Trough Plasma Concentration (Cmin) of EVER001	Plasma EVER001 trough concentration (Cmin)	Throughout the study period, up to Week 56
Time to Reach Peak Concentration (Tmax) of EVER00	Time to reach peak concentration (Tmax) of EVER001	Throughout the study period, up to Week 56
Accumulation Ratio (AR) of EVER001	Accumulation ratio (AR) of EVER001	Throughout the study period, up to Week 56

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Nephrosis; Glomerulonephritis, IGA; Glomerulosclerosis, Focal Segmental; Nephrosis, Lipoid
• Other Study ID Numbers: ES108001-001; CTR20260886 (Registry Identifier: A Study to Evaluate the Efficacy and Safety of EVER001 in Patients with Selected Glomerular Diseases)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No