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EVER001

Phase 1

Primary Membranous Nephropathy | Small molecule | Other |China Pharma Holdings, Inc.|Last Updated: May 31, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05800873Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001PHASE1 RECRUITING 30 — — May 15, 2023Sep 15, 2026May 31, 202519 China
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Study Endpoints
Primary Endpoints
adverse events
104 weeks.
clinical laboratory assessments.
104 weeks.
vital signs.
104 weeks.
physical examination
104 weeks
ECG.
104 weeks.
Secondary Endpoints
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.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EVER001 100mgEXPERIMENTALEVER001 100mg QD for 4 weeks, followed by EVER001 100mg BID for 32 weeks.
EVER001 200mgEXPERIMENTALEVER001 200mg BID for 36 weeks.
Interventions
NameTypeDescription
EVER001DRUGA highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites19

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 protein...

Countries:China
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