NCT07614477RecruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 5 May 2026
- Start date
- 20 May 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Everest Medicines (China) Co.,Ltd.
- Diseases
- IgA nephropathy
- NCT number
- NCT07614477
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 45
- From 20 May 2026 to the primary completion date, 31 Dec 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with current or prior inadequately treated active tuberculosis (TB), latent TB, or evidence of current household contact with active TB
Other illness
- 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
- At risk of bleeding
Lab values
- Baseline 24-hour UPCR \> 3 g/g and serum albumin \< 30 g/L in participants with IgAN
Other
- Hereditary or secondary FSGS/MCD; collapsing FSGS
- BMI ≥ 35 kg/m² in participants with FSGS/MCD
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.