Evaluating a new treatment for primary membranous nephropathy

A Phase 1b/2 Study To Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001 In Participants With Selected Proteinuric Glomerular Diseases

This study is testing a new oral medication called EVER001 to see if it can help people with primary membranous nephropathy feel better compared to current treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Everest Medicines (China) Co.,Ltd. (Industry-sponsored)
• Drugs / interventions: rituximab, Cyclophosphamide, prednisone
• Locations: 19 sites (Changsha, Changsha and 18 other locations)
• Trial ID: NCT05800873 on ClinicalTrials.gov

What this trial studies

This study evaluates EVER001, a selective oral Bruton tyrosine kinase inhibitor, for its efficacy, safety, pharmacokinetics, and pharmacodynamics in patients with primary membranous nephropathy. Participants must have a confirmed diagnosis and specific proteinuria levels, and the study aims to assess how well this treatment works compared to existing therapies. The trial is designed to gather data on how the drug is processed in the body and its effects on the disease.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with primary membranous nephropathy who have high levels of proteinuria and have not responded to standard supportive therapies.

Not a fit: Patients with non-primary membranous nephropathy or those with unstable kidney function are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with primary membranous nephropathy by reducing proteinuria and preserving kidney function.

How similar studies have performed: While this approach is novel, similar studies targeting proteinuric glomerular diseases have shown promise, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Having clinical diagnosis of primary membranous nephropathy, as verified by biopsy.
2. Have positive anti-PLA2R autoantibody test results \> 20 relative units (RU)/ml.
3. During screening at least one testing of proteinuria must be \>3.5 g/24h.
4. Have nephrotic range proteinuria for at least 8 weeks prior to Day 1 and no improvement (\<50% reduction) despite supportive therapy of ACE inhibitor or ARB unless contraindicated, for patients who have two tests of proteinuria during screening ≥8.0g/24h, the duration of nephrotic range proteinuria for at least 8 weeks is not required.

Exclusion Criteria:

1. Non-primary membranous nephropathy or other condition affecting the kidney.
2. eGFR at screening \< 45 mL/min/1.73m2 or kidney function not stable .
3. Uncontrolled hypertension .
4. Serum albumin level at screening # 25g/l.
5. Have received: B-cell targeted therapy except rituximab at any time;Rituximab and the biosimilars within 2 years (participants with rituximab treatment between 1 and 2 years prior to Day 1 are eligible if there is documented evidence of B-cell repopulation to \>90% of Lower Limits of Normal Range.); Cyclophosphamide or Chlorambucil within 180 days;other immunosuppressive/immunomodulatory agents within 90 days;greater than 30mg/day prednisone or equivalence within 30 days.
6. Acute or chronic infection,including positivity of tuberculosis infection test.
7. Positive serology for TP,HIV, HBV, or HCV.
8. Lab testing abnormality as: WBC\< 3000/mm³, Lymphocyte \< 1000/ mm³, neutrophil \<1500/mm³, Hb \< 80g/L, Platelet count \<100×10e9/ L, Prothrombin time\>1.5×ULN, Activated partial thromboplastin time ≥1.5×ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 1.5×ULN, alkaline phosphatase and bilirubin \>1.5×ULN.
9. Judged by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.

Where this trial is running

Changsha, Changsha and 18 other locations

• The Second Xiangya Hospital Of Central South University — Changsha, Changsha, China (Recruiting)
• The First Affiliated Hospital of PLA Army Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
• The Third Affiliated Hospital,Sun Yat Sen University — Guangzhou, Guangdong, China (Recruiting)
• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Recruiting)
• The Second Affiliated Hospital of Harbin Medical University — Harbin, Harbin, China (Recruiting)
• Xiangya Third Hospital, Central South University — Changsha, Hunan, China (Recruiting)
• The First Affiliated Hospital of Baotou Medical College — Baotou, Inner Mongolia, China (Recruiting)
• Zhongda Hospital Southeast University — Nanjing, Jiangsu, China (Recruiting)
• The Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
• The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
• The First Affiliated Hospital of Medical college of Xi'an Jiaotong University — Xian, Shanxi, China (Recruiting)
• Sichuan Province People's Hospital — Chengdu, Sichuan, China (Recruiting)
• Second Hospital of Shanxi Medical University — Shanxi, Taiyuan, China (Recruiting)
• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
• The first affliated hospital of NingBo university — Ningbo, Zhejiang, China (Recruiting)
• Taizhou Hospital of Zhejiang Province — Taizhou, Zhejiang, China (Recruiting)
• Peking University First Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Lixia Wang

Conditions Primary Membranous Nephropathy