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

Официальное название

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)

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Percentage change from baseline in 24-hour urine protein-to-creatinine ratio (UPCR) [Срок оценки: Week24]
• Treatment-emergent adverse events (TEAEs) [Срок оценки: Throughout the study period, up to Week 56]
• Adverse events of special interest (AESIs) [Срок оценки: Throughout the study period, up to Week 56]
• Systolic blood pressure change from baseline [Срок оценки: Throughout the study period, up to Week 56]
• Body weight change from baseline [Срок оценки: Throughout the study period, up to Week 56]
• Change from baseline in clinical laboratory safety parameters [Срок оценки: Throughout the study period, up to Week 56]
• Physical examination findings [Срок оценки: Throughout the study period, up to Week 56]
• Chest radiography findings [Срок оценки: Throughout the study period, up to Week 56]
• 12-lead electrocardiogram (ECG) findings [Срок оценки: Throughout the study period, up to Week 56]
• Pulse rate change from baseline [Срок оценки: Throughout the study period, up to Week 56]

Вторичные конечные точки (12)

• Percentage change from baseline in 24-hour UPCR [Срок оценки: Week 2 and thereafter, up to Week 56]
• Proportion of participants achieving complete remission (CR) [Срок оценки: Week 2 and thereafter, up to Week 56]
• Proportion of IgAN participants with ≥30% reduction in 24-hour UPCR from baseline [Срок оценки: At Week 24, Week 36, and Week 52]
• Change from baseline in estimated glomerular filtration rate (eGFR) [Срок оценки: Week 2 and thereafter, up to Week 56]
• eGFR slope from baseline [Срок оценки: Baseline to Week 52]
• Percentage change from baseline in serum albumin [Срок оценки: Week 2 and thereafter, up to Week 56]
• Proportion of participants achieving partial remission (PR) [Срок оценки: Week 2 and thereafter, up to Week 56]
• Proportion of participants achieving CR or PR [Срок оценки: Week 2 and thereafter, up to Week 56]
• Time to achieve CR or PR [Срок оценки: Baseline to Week 52]
• Proportion of participants with relapse (CR/PR, no rescue therapy) [Срок оценки: From Day1 to Week 52]
• Time from CR/PR to relapse [Срок оценки: From Day1 to Week 52]
• Cumulative dose of glucocorticoids (GC) [Срок оценки: Week 16, Week 24, Week 32, Week 40, and Week 52]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Peking University First Hospital — Пекин
• Tianjin Medical University General Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07614477 · ES108001-001 · CTR20260886

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)
• NMPA/CDE CTR20260886 (платформа chinadrugtrials.org.cn)

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