Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001

NCT05800873 | Recruiting Phase 1

• 1 other identifier: ES108001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 19

Brief 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.

Conditions

Primary Membranous Nephropathy

Outcome Measures

Primary Outcomes (5)

• adverse events

  104 weeks.

• clinical laboratory assessments.

  104 weeks.

• vital signs.

  104 weeks.

• physical examination

  104 weeks

• ECG.

  104 weeks.

Secondary Outcomes (6)

• To evaluate whether EVER001 can modulate proteinuria in pMN.

  52 weeks.

• To evaluate whether EVER001 can modulate anti-PLA2R autoantibodies in patients with positive baseline levels of these antibodies.

  52 weeks.

• To evaluate the clinical response and immunological response in pMN.

  104 weeks.

• Maximum Observed Plasma Concentration (Cmax) of EVER001

  52 weeks.

• Minimum Observed Plasma Concentration (Cmin) of EVER001

  52 weeks.

Study Arms (2)

EVER001 100mg

EXPERIMENTAL

EVER001 100mg QD for 4 weeks, followed by EVER001 100mg BID for 32 weeks.

Drug: EVER001

EVER001 200mg

EXPERIMENTAL

EVER001 200mg BID for 36 weeks.

Drug: EVER001

Interventions

EVER001 DRUG

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

EVER001 100mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having clinical diagnosis of primary membranous nephropathy, as verified by biopsy.
• Have positive anti-PLA2R autoantibody test results \> 20 relative units (RU)/ml.
• During screening at least one testing of proteinuria must be \>3.5 g/24h.
• 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.

You may not qualify if:

• Non-primary membranous nephropathy or other condition affecting the kidney.
• eGFR at screening \< 45 mL/min/1.73m2 or kidney function not stable .
• Uncontrolled hypertension .
• Serum albumin level at screening # 25g/l.
• 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.
• Acute or chronic infection,including positivity of tuberculosis infection test.
• Positive serology for TP,HIV, HBV, or HCV.
• 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.
• Judged by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.

Sponsors & Collaborators

• Everest Medicines (China) Co.,Ltd.: lead

Study Sites (19)

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

Central Study Contacts

Lixia Wang

CONTACT

00862180123250; lixia.wang@everestmedicines.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 6, 2023
• Study Start: May 15, 2023
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (19)