ClinicalTrials.gg
CompletedNCT05800873Updated Sep 15, 2026

Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001

A Phase 1 interventional study of EVER001 and EVER001 in Primary Membranous Nephropathy, sponsored by Everest Medicines (China) Co.,Ltd.. Completed at 19 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Everest Medicines (China) Co.,Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
31
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Primary Membranous Nephropathy
03

In context

Glomerulonephritis, Membranous

144 studies on the registry are indexed under Glomerulonephritis, Membranous; 58 are open to participants now.

This study's enrollment of 31 is below the median of 46 across 105 interventional studies indexed under Glomerulonephritis, Membranous.

Browse Glomerulonephritis, Membranous studies →

Lead sponsor

Everest Medicines (China) Co.,Ltd. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Having clinical diagnosis of primary membranous nephropathy, as verified by .
  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 , 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

Exclusion Criteria:

  1. Non-primary membranous nephropathy or other condition affecting the kidney.
  2. 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 /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,, , or .
  8. Lab testing abnormality as: WBC\< 3000/mm³, Lymphocyte \< 1000/ mm³, neutrophil \<1500/mm³, \< 80g/L, count \<100×10e9/ L, >1.5×, Activated partial thromboplastin time ≥1.5×ULN, (AST) and alanine aminotransferase (ALT) ≥ 1.5×ULN, alkaline phosphatase and >1.5×ULN.
  9. Judged by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.
Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    EVER001 100mg

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

    Drug: EVER001

  • Experimental
    EVER001 200mg

    EVER001 200mg BID for 36 weeks.

    Drug: EVER001

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.

06

What researchers measure

Primary outcomes

  1. adverse events

    Time frame: 104 weeks.

  2. clinical laboratory assessments.

    Time frame: 104 weeks.

  3. vital signs.

    Time frame: 104 weeks.

  4. physical examination

    Time frame: 104 weeks

  5. ECG.

    Time frame: 104 weeks.

Secondary outcomes

  1. To evaluate whether EVER001 can modulate proteinuria in pMN.

    Percentage change from baseline of 24 hr proteinuria throughout 52 weeks.

    Time frame: 52 weeks.

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

    Percentage change from baseline of anti-PLA2R autoantibody level throughout 52 weeks.

    Time frame: 52 weeks.

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

    To evaluate the clinical response and immunological response in pMN.

    Time frame: 104 weeks.

  4. Maximum Observed Plasma Concentration (Cmax) of EVER001

    Time frame: 52 weeks.

  5. Minimum Observed Plasma Concentration (Cmin) of EVER001

    Time frame: 52 weeks.

  6. Time to Reach Maximum Observed Concentration (Tmax) of EVER001.

    Time frame: 52 weeks.

07

Study locations

19 sites
  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05800873
Lead sponsor
Everest Medicines (China) Co.,Ltd.
Responsible party
Sponsor
First posted
Apr 6, 2023
Start date
May 15, 2023
Primary completion
Jul 27, 2026
Completion
Jul 27, 2026
Last update
Sep 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion