RecruitingPhase 1NCT05800873

Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001

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


Sponsor

Everest Medicines (China) Co.,Ltd.

Enrollment

30 participants

Start Date

May 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

EVER001 is a highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases, which is being developed to treat proteinuric glomerular diseases. The overall aim of the study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of EVER001 in subjects with selected proteinuric glomerular diseases. The first targeted disease is primary membranous nephropathy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the safety, effectiveness, and how the body processes a new investigational drug called EVER001 for the treatment of primary membranous nephropathy (MN). Primary membranous nephropathy is a kidney disease in which the body's immune system mistakenly attacks proteins on the kidney's own filtering cells, causing protein to leak into the urine (a condition called nephrotic syndrome). This leads to severe swelling, vulnerability to blood clots and infections, and eventually kidney failure if untreated. The main target in most cases is a protein called PLA2R, and the immune attack is driven by a specific type of immune cell called B cells. Eligible participants are adults aged 18 to 75 with a biopsy-proven diagnosis of primary membranous nephropathy who have high levels of the PLA2R antibody in their blood, protein leakage in their urine above a certain threshold despite supportive treatment with blood pressure medications, and adequate kidney function (eGFR above 45). Participants receive EVER001 by injection and are followed to measure changes in urinary protein, antibody levels, kidney function, and safety markers over time. This research is significant because existing treatments for MN — including immunosuppressive chemotherapy and rituximab — carry substantial risks and are not effective for all patients. A targeted therapy like EVER001 that specifically blocks the B cell response driving the disease could offer a safer and more effective option for patients living with this difficult kidney condition.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEVER001

A highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases.

DRUGEVER001

A highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases.


Locations(19)

The Second Xiangya Hospital Of Central South University

Changsha, Changsha, China

The First Affiliated Hospital of PLA Army Medical University

Chongqing, Chongqing Municipality, China

The Third Affiliated Hospital,Sun Yat Sen University

Guangzhou, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

The Second Affiliated Hospital of Harbin Medical University

Harbin, Harbin, China

Xiangya Third Hospital, Central South University

Changsha, Hunan, China

The First Affiliated Hospital of Baotou Medical College

Baotou, Inner Mongolia, China

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Medical college of Xi'an Jiaotong University

Xian, Shanxi, China

Sichuan Province People's Hospital

Chengdu, Sichuan, China

Second Hospital of Shanxi Medical University

Shanxi, Taiyuan, China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

The first affliated hospital of NingBo university

Ningbo, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

Peking University First Hospital

Beijing, China

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NCT05800873


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