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

Everest Medicines

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: EVER001

Study type: Interventional

Funder types: Industry

Identifiers

NCT07614477

ES108001-001

CTR20260886 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

EVER001 200mg bid

Experimental group

Description:

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

Treatment:

Drug: EVER001