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Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases

3. august 2026 oppdatert av: Everest Medicines (China) Co.,Ltd.

The Sub-Study 3 of A Phase 1b/2 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases (ES108001)

This is a Phase 1b/2, open-label, multi-center study evaluating the therapeutic potential and safety of the investigational drug EVER001 in adults with FSGS, MCD, or IgAN. EVER001 acts on multiple immune pathways without directly affecting T cells or depleting B cells (both are lymphocytes). The study will be conducted at ~30 centers in China, enrolling 45 participants aged 18-75 years (15 per indication). The IMP is a 100 mg oral capsule, dosed at 200 mg twice daily (2 capsules per dose, 4 daily) for 52 weeks.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

45

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100730
        • Rekruttering
        • Peking University First Hospital
        • Ta kontakt med:
    • Hebei
      • Tianjin, Hebei, Kina
        • Rekruttering
        • Tianjin Medical University General Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Primary FSGS or MCD/IgAN confirmed by renal biopsy
  • eGFR ≥ 45 mL/min/1.73 m²
  • For participants with FSGS or MCD: must have a 24-hour urine protein-to-creatinine ratio (UPCR) > 3.5 g/g and serum albumin < 30 g/L during the screening period
  • For participants in the IgAN group: 24-hour UPCR ≥ 0.8 g/g; ARB or ACEI stable for ≥ 12 weeks prior to Day 1
  • Patients with FSGS or MCD who have not been treated with immunosuppressants or are sensitive to prior immunosuppressant treatment

Exclusion Criteria:

  • Hereditary or secondary FSGS/MCD; collapsing FSGS
  • BMI ≥ 35 kg/m² in participants with FSGS/MCD
  • Evidence of diabetes mellitus or a history of diabetes mellitus
  • Acute or chronic infection requiring treatment
  • Patients infected with HIV, hepatitis C, syphilis, or hepatitis B
  • Patients with current or prior inadequately treated active tuberculosis (TB), latent TB, or evidence of current household contact with active TB
  • At risk of bleeding
  • Baseline 24-hour UPCR > 3 g/g and serum albumin < 30 g/L in participants with IgAN

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: EVER001 200mg bid
Participants in this arm receive EVER001 200 mg administered twice daily (bid) orally. This single-arm cohort evaluates the efficacy and safety of EVER001 in subjects with FSGS, MCD, and IgA
Legemiddel: EVER001
EVER001 200 mg, oral administration, twice daily (bid), for the treatment of proteinuric glomerular diseases including FSGS , MCD , and IgA

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage change from baseline in 24-hour urine protein-to-creatinine ratio (UPCR)
Tidsramme: Week24
Percentage change from baseline in 24-hour UPCR (based on 24-hour urine collection)
Week24
Treatment-emergent adverse events (TEAEs)
Tidsramme: Throughout the study period, up to Week 56
Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs)
Throughout the study period, up to Week 56
Adverse events of special interest (AESIs)
Tidsramme: Throughout the study period, up to Week 56
Incidence of adverse events of special interest (AESIs)
Throughout the study period, up to Week 56
Systolic blood pressure change from baseline
Tidsramme: Throughout the study period, up to Week 56
Measured in mmHg using a calibrated clinical blood pressure monitor
Throughout the study period, up to Week 56
Body weight change from baseline
Tidsramme: Throughout the study period, up to Week 56
Measured in kilograms (kg) using a calibrated clinical scale
Throughout the study period, up to Week 56
Change from baseline in clinical laboratory safety parameters
Tidsramme: Throughout the study period, up to Week 56
Change from baseline in routine clinical laboratory safety parameters, measured using standard validated clinical laboratory assays and reported in standard clinical units
Throughout the study period, up to Week 56
Physical examination findings
Tidsramme: Throughout the study period, up to Week 56
Incidence of new or worsening abnormalities in physical examination findings, assessed at scheduled study visits.
Throughout the study period, up to Week 56
Chest radiography findings
Tidsramme: Throughout the study period, up to Week 56
Incidence of new or worsening abnormalities in chest radiography findings, assessed at scheduled study visits.
Throughout the study period, up to Week 56
12-lead electrocardiogram (ECG) findings
Tidsramme: Throughout the study period, up to Week 56
Incidence of new or worsening abnormalities in 12-lead electrocardiogram (ECG) findings, assessed at scheduled study visits.
Throughout the study period, up to Week 56
Pulse rate change from baseline
Tidsramme: Throughout the study period, up to Week 56
Measured in beats per minute (bpm) using a calibrated vital signs monitor
Throughout the study period, up to Week 56
Diastolic blood pressure change from baseline
Tidsramme: Throughout the study period, up to Week 56
Measured in mmHg using a calibrated clinical blood pressure monitor
Throughout the study period, up to Week 56
Body temperature change from baseline
Tidsramme: Throughout the study period, up to Week 56
Measured in degrees Celsius (°C) using a calibrated clinical thermometer
Throughout the study period, up to Week 56

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage change from baseline in 24-hour UPCR
Tidsramme: Week 2 and thereafter, up to Week 56
Percentage change from baseline in 24-hour urine protein-to-creatinine ratio (UPCR)
Week 2 and thereafter, up to Week 56
Proportion of participants achieving complete remission (CR)
Tidsramme: Week 2 and thereafter, up to Week 56
Proportion of participants achieving complete remission (CR) based on predefined criteria
Week 2 and thereafter, up to Week 56
Proportion of IgAN participants with ≥30% reduction in 24-hour UPCR from baseline
Tidsramme: At Week 24, Week 36, and Week 52
Proportion of participants with IgAN achieving ≥30% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) from baseline, assessed at Week 24, Week 36, and Week 52
At Week 24, Week 36, and Week 52
Change from baseline in estimated glomerular filtration rate (eGFR)
Tidsramme: Week 2 and thereafter, up to Week 56
Absolute and percentage change from baseline in estimated glomerular filtration rate (eGFR), calculated per the formula specified in the study protocol
Week 2 and thereafter, up to Week 56
eGFR slope from baseline
Tidsramme: Baseline to Week 52
Slope of change in estimated glomerular filtration rate (eGFR, calculated per the formula specified in the study protocol) from baseline to Week 52
Baseline to Week 52
Percentage change from baseline in serum albumin
Tidsramme: Week 2 and thereafter, up to Week 56
Percentage change from baseline in serum albumin level
Week 2 and thereafter, up to Week 56
Proportion of participants achieving partial remission (PR)
Tidsramme: Week 2 and thereafter, up to Week 56
Proportion of participants achieving partial remission (PR) based on predefined study criteria
Week 2 and thereafter, up to Week 56
Proportion of participants achieving CR or PR
Tidsramme: Week 2 and thereafter, up to Week 56
Proportion of participants achieving complete remission (CR) or partial remission (PR) based on predefined study criteria
Week 2 and thereafter, up to Week 56
Time to achieve CR or PR
Tidsramme: Baseline to Week 52
Time from baseline to first documented complete remission (CR) or partial remission (PR), based on predefined study criteria
Baseline to Week 52
Proportion of participants with relapse (CR/PR, no rescue therapy)
Tidsramme: From Day1 to Week 52
Proportion of participants who experience relapse among those achieving CR or PR during the study and not receiving rescue therapy
From Day1 to Week 52
Time from CR/PR to relapse
Tidsramme: From Day1 to Week 52
Time from first documented complete remission (CR) or partial remission (PR) to first documented relapse
From Day1 to Week 52
Cumulative dose of glucocorticoids (GC)
Tidsramme: Week 16, Week 24, Week 32, Week 40, and Week 52
Cumulative dose of glucocorticoids (GC), measured in prednisone equivalent dose, calculated at the specified study visits
Week 16, Week 24, Week 32, Week 40, and Week 52
Proportion requiring GC increase or additional immunosuppressants
Tidsramme: Throughout the study period (baseline to Week 56)
Proportion of participants requiring increase in GC dosage and/or initiation of additional immunosuppressants
Throughout the study period (baseline to Week 56)
Proportion of IgAN participants with positive hematuria
Tidsramme: At baseline, Week 12, Week 24, Week 36, and Week 52
Proportion of participants with IgAN with positive hematuria
At baseline, Week 12, Week 24, Week 36, and Week 52
Resolution of hematuria in IgAN participants
Tidsramme: At Week 12, Week 24, Week 36, and Week 52
Resolution of hematuria in participants with IgA
At Week 12, Week 24, Week 36, and Week 52
Change from baseline in BTK target occupancy
Tidsramme: Throughout the study period, up to Week 56
Change from baseline in BTK target occupancy in peripheral blood cells
Throughout the study period, up to Week 56
Plasma EVER001 peak concentration (Cmax)
Tidsramme: Throughout the study period, up to Week 56
Plasma EVER001 peak concentration (Cmax)
Throughout the study period, up to Week 56
Trough Plasma Concentration (Cmin) of EVER001
Tidsramme: Throughout the study period, up to Week 56
Plasma EVER001 trough concentration (Cmin)
Throughout the study period, up to Week 56
Time to Reach Peak Concentration (Tmax) of EVER00
Tidsramme: Throughout the study period, up to Week 56
Time to reach peak concentration (Tmax) of EVER001
Throughout the study period, up to Week 56
Accumulation Ratio (AR) of EVER001
Tidsramme: Throughout the study period, up to Week 56
Accumulation ratio (AR) of EVER001
Throughout the study period, up to Week 56

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Everest Medicines (China) Co.,Ltd.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. mai 2026

Primær fullføring (Antatt)

31. desember 2028

Studiet fullført (Antatt)

31. mars 2029

Datoer for studieregistrering

Først innsendt

5. mai 2026

Først innsendt som oppfylte QC-kriteriene

22. mai 2026

Først lagt ut (Faktiske)

29. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. august 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ES108001-001
  • CTR20260886 (Registeridentifikator: A Study to Evaluate the Efficacy and Safety of EVER001 in Patients with Selected Glomerular Diseases)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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