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Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions (ASPIRE-202)

24. august 2026 oppdatert av: AusperBio Therapeutics Inc.

A Phase 2 Multi-center, Randomized, Open-label Study to Assess the Efficacy and Safety of AHB-137 in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B in the North America and Europe Regions

This study is a randomized, open-label, multicenter phase 2 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with CHB treated with Nucleos(t)ide Analogue (NAs).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

70

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Har ikke rekruttert ennå
        • University Of Calgary
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Har ikke rekruttert ennå
        • Toronto General Hospital
  • Forente stater
    • California
      • Palo Alto, California, Forente stater, 94304-1509
        • Har ikke rekruttert ennå
        • Stanford University
    • Maryland
      • Baltimore, Maryland, Forente stater, 21201-1009
        • Har ikke rekruttert ennå
        • University of Maryland
    • New York
      • New York, New York, Forente stater, 10016
        • Har ikke rekruttert ennå
        • NYU Langone Health
    • Texas
      • San Antonio, Texas, Forente stater, 78215-2100
        • Rekruttering
        • Texas Liver Institute
  • Frankrike
      • Clichy, Frankrike, 92118
        • Har ikke rekruttert ennå
        • Hopital Beaujon
  • Italia
    • Milan
      • Milan, Milan, Italia, 20122
        • Har ikke rekruttert ennå
        • Clinica Mangiagalli
  • Spania
    • Barcelona
      • Barcelona, Barcelona, Spania, 8035
        • Har ikke rekruttert ennå
        • Vall d'Hebron Hospital
  • Storbritannia
    • London
      • London, London, Storbritannia, SE5 9RS
        • Har ikke rekruttert ennå
        • King's College Hospital

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:

Participants are eligible to be included in the study only if all of the following criteria apply:

  1. Adults ≥18 years of age and up to 65 years of age (inclusive) at Screening who are able to provide informed consent, comply with study procedures, and agree to discontinue nucleos(t)ide analog (NA) therapy if protocol-defined discontinuation criteria are met.
  2. Body mass index (BMI) ≤35 kg/m².
  3. Documented chronic hepatitis B virus (HBV) infection for ≥6 months prior to randomization, defined by hepatitis B surface antigen (HBsAg) positivity or detectable HBV DNA.
  4. Receiving stable, approved nucleos(t)ide analog (NA) monotherapy for ≥6 months prior to randomization.
  5. HBV DNA meeting protocol-specified virologic criteria at Screening.
  6. Hepatitis B surface antigen (HBsAg) level meeting protocol-specified virologic criteria at Screening.
  7. Alanine aminotransferase (ALT) meeting protocol-specified criteria at Screening.
  8. Screening electrocardiogram (ECG) without clinically significant abnormalities and with a Fridericia-corrected QT interval (QTcF) ≤450 msec for males or ≤470 msec for females.
  9. Females of childbearing potential must not be breastfeeding and must have a negative serum pregnancy test at Screening and a negative urine pregnancy test prior to first dose.
  10. Males and female participants of childbearing potential must agree to use protocol-specified effective contraception during the dosing period and for ≥6 months after the last dose of AHB-137.

Exclusion Criteria:

Participants will be excluded from the study if any of the following criteria apply:

  1. Clinically significant disease other than chronic hepatitis B virus (HBV) infection.
  2. Concomitant clinically significant liver disease.
  3. Any severe infection (other than chronic HBV infection) within 1 month prior to randomization.
  4. History of immune thrombocytopenia.
  5. Current suspected liver cirrhosis and/or evidence of cirrhosis by protocol-specified criteria for FibroScan® or equivalent imaging modality (e.g., ultrasound elastography); historical FibroScan® (or equivalent) results with documentation within 6 months from screening is acceptable.
  6. History of liver cirrhosis defined by liver biopsy or by FibroScan® or equivalent imaging modality using protocol-specified criteria.
  7. Prior history of, current diagnosis of, or suspected hepatocellular carcinoma (HCC), or alpha-fetoprotein (AFP) ≥20 ng/mL at Screening.
  8. History of extrahepatic diseases potentially associated with HBV infection.
  9. Laboratory evidence of active infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV), or active syphilis. Participants with positive HCV or HDV serology and documented negative HCV RNA or HDV RNA, respectively, are eligible.
  10. Protocol-specified abnormal laboratory values at Screening.
  11. History of vasculitis or presence of signs or symptoms suggestive of vasculitis, or history or presence of diseases associated with vasculitis.
  12. History of malignancy within 5 years prior to Screening, except for adequately treated non-melanoma skin cancer. Participants currently undergoing evaluation for potential malignancy are excluded.
  13. History of hypersensitivity or allergy to any component of the investigational product (IP).
  14. Major trauma or major surgery within 3 months prior to Screening, or planned surgery during the study period unless eligibility is confirmed by the Medical Monitor.
  15. Current alcohol or substance abuse judged by the Investigator to potentially interfere with participant compliance.
  16. Female participants who are pregnant, breastfeeding, planning pregnancy during the study, or unwilling to refrain from egg donation and/or in vitro fertilization during the study.

  17. Participation in another clinical trial or receipt of any investigational product prior to first dose in this study within:

    1. Five half-lives (if known) or twice the duration of biological effect (if known), whichever is longer, or
    2. Six months, if neither half-life nor duration of effect is known
  18. Prior treatment with antisense oligonucleotides (ASOs) or small interfering RNA (siRNA)-based therapies.

  19. Any of the following prior or concomitant therapies:

    1. Prolonged use of immunomodulators (e.g., corticosteroids, methotrexate), cytotoxic drugs, or biologics (e.g., monoclonal antibodies) within 6 months prior to first IP administration, except for short-term treatment (≤2 weeks) or topical/inhaled corticosteroids
    2. Interferon therapy within 12 months prior to first dose
    3. Vaccination within 1 month prior to Screening, except for influenza or SARS-CoV-2 (COVID-19) vaccination or booster
    4. Current treatment with bulevirtide
  20. Requirement for long-term regular use of anticoagulants (e.g., warfarin, factor Xa inhibitors) or antiplatelet agents (e.g., clopidogrel or regular aspirin), except for low-dose aspirin.
  21. Any other condition or circumstance that, in the Investigator's judgment, would make the participant unsuitable for participation in the study.

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: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm A: Dose Regimen A
Participants receive AHB-137 according to dosing regimen A.
Legemiddel: AHB-137
Subkutan injeksjon
Eksperimentell: Arm B: Dose Regimen B
Participants receive AHB-137 according to dosing regimen B.
Legemiddel: AHB-137
Subkutan injeksjon

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ)
Tidsramme: 24 Weeks post AHB-137 treatment (Week 48)
24 Weeks post AHB-137 treatment (Week 48)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Andel deltakere som oppfyller kriteriene for å avslutte nukleos(t)id analog (NA)-behandling
Tidsramme: Uke 48
Uke 48
Andel deltakere med anti-HBs serokonvertering (med overflateantistoff mot hepatitt B [HBsAb] > 10 IU/L)
Tidsramme: Uke 24, 48 og 72
Uke 24, 48 og 72
Andel deltakere som opplever virologisk tilbakefall
Tidsramme: Fra baseline gjennom uke 72
Fra baseline gjennom uke 72
Areal under plasmakonsentrasjon-tid-kurven (AUC) for AHB-137
Tidsramme: Fra første dose (dag 1) til slutten av farmakokinetisk prøvetaking (uke 48)
Fra første dose (dag 1) til slutten av farmakokinetisk prøvetaking (uke 48)
Konsentrasjon ved slutten av doseringsintervallet (Ct) av AHB-137
Tidsramme: Fra første dose (dag 1) gjennom slutten av farmakokinetisk prøvetaking (uke 48)
Fra første dose (dag 1) gjennom slutten av farmakokinetisk prøvetaking (uke 48)
Maksimal observert plasmakoncentrasjon (Cmax) av AHB-137
Tidsramme: Fra første dose (dag 1) gjennom slutten av farmakokinetisk prøvetaking (uke 48)
Fra første dose (dag 1) gjennom slutten av farmakokinetisk prøvetaking (uke 48)
Tid til maksimal observert plasmakonsentrasjon (Tmax) for AHB-137
Tidsramme: Fra første dose (dag 1) gjennom slutten av farmakokinetisk prøvetaking (uke 48)
Fra første dose (dag 1) gjennom slutten av farmakokinetisk prøvetaking (uke 48)
Tilsynelatende plasmarensning (CL/F) av AHB-137
Tidsramme: Fra første dose (dag 1) gjennom til slutten av farmakokinetisk prøvetaking (uke 48)
Fra første dose (dag 1) gjennom til slutten av farmakokinetisk prøvetaking (uke 48)
Proportion of participants with HBsAg < LOD and HBV DNA < LLOQ
Tidsramme: Off-treatment follow-up (Week 48 to 72)
Off-treatment follow-up (Week 48 to 72)
Proportion of participants with HBsAg < LOD
Tidsramme: Week 72
Week 72
Proportion of participants with HBV DNA < LLOQ
Tidsramme: From baseline through Week 72
From baseline through Week 72
Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA post AHB-137 treatment
Tidsramme: 24 weeks post AHB-137 treatment
24 weeks post AHB-137 treatment
Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA at weeks 48 and 72
Tidsramme: 24 weeks post AHB-137 treatment and at Week 72
24 weeks post AHB-137 treatment and at Week 72
Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA
Tidsramme: From baseline through end of study (Week 72)
From baseline through end of study (Week 72)
Proportion of participants with HBsAg < or ≥ LOD (0.05 IU/mL) and/or HBV DNA < or ≥ LLOQ
Tidsramme: From baseline through end of study (Week 72)
From baseline through end of study (Week 72)
Proportion of participants with highly sensitive HBsAg < LOD (0.005 IU/mL)
Tidsramme: From baseline through end of study (Week 72)
From baseline through end of study (Week 72)
Proportion of participants with protocol-defined levels of HBsAg
Tidsramme: From baseline through end of study (Week 72)
From baseline through end of study (Week 72)
Categorical change from baseline in HBsAg levels, defined as reductions of ≥0.5, ≥1.0, ≥1.5, ≥2.0, or ≥3.0 log₁₀ IU/mL, assessed at each scheduled study visit
Tidsramme: From baseline through end of study (Week 72)
From baseline through end of study (Week 72)
Quantitative hepatitis B virologic and serologic markers over time
Tidsramme: From baseline through end of study (Week 72)
Actual values and change from baseline over time in available quantitative hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B virus (HBV) DNA, HBV ribonucleic acid (RNA), hepatitis B core-related antigen (HBcrAg), hepatitis B e antibody (HBeAb), and qualitative and/or quantitative hepatitis B e antigen (HBeAg), summarized descriptively.
From baseline through end of study (Week 72)
Time from nucleos(t)ide analog (NA) therapy discontinuation to virologic relapse
Tidsramme: From NA therapy discontinuation (Week 48) through end of follow-up (Week 72)
From NA therapy discontinuation (Week 48) through end of follow-up (Week 72)
Change from baseline in alanine aminotransferase (ALT)
Tidsramme: From baseline through end of study (Week 72)
From baseline through end of study (Week 72)
Proportion of participants with baseline ALT above the upper limit of normal (ULN) who achieve ALT normalization
Tidsramme: From baseline through end of study (Week 72)
From baseline through end of study (Week 72)
Proportion of patients with drug-resistant mutations
Tidsramme: From baseline through end of study (Week 72)
From baseline through end of study (Week 72)
Proportion of participants with treatment-emergent adverse events (TEAEs)
Tidsramme: From first dose (Day 1) through end of study (Week 72)
Proportion of participants who experience treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation of study treatment.
From first dose (Day 1) through end of study (Week 72)
Proportion of participants with detectable anti-drug antibody (ADA) to AHB-137 and corresponding ADA titers
Tidsramme: From baseline through end of study (Week 72)
From baseline through end of study (Week 72)
Area Under the Plasma Concentration-Time Curve (AUC) of AHB-137
Tidsramme: From first dose (Day 1) through end of study (Week 72)
From first dose (Day 1) through end of study (Week 72)
Plasma Concentration of AHB-137 at the End of the Dosing Interval (Cτ)
Tidsramme: From first dose (Day 1) through end of study (Week 72)
From first dose (Day 1) through end of study (Week 72)
Maximum Observed Plasma Concentration (Cmax) of AHB-137
Tidsramme: From first dose (Day 1) through end of study (Week 72)
From first dose (Day 1) through end of study (Week 72)
Time to Maximum Observed Plasma Concentration (Tmax) of AHB-137
Tidsramme: From first dose (Day 1) through end of study (Week 72)
From first dose (Day 1) through end of study (Week 72)
Apparent Plasma Clearance (CL/F) of AHB-137
Tidsramme: From first dose (Day 1) through end of study (Week 72)
From first dose (Day 1) through end of study (Week 72)

Samarbeidspartnere og etterforskere

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

Sponsor

AusperBio Therapeutics Inc.

Etterforskere

  • Studieleder: Audrey Lau, MD, PhD, AusperBio Therapeutics Inc.

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 (Antatt)

27. august 2026

Primær fullføring (Antatt)

11. mai 2027

Studiet fullført (Antatt)

26. juli 2028

Datoer for studieregistrering

Først innsendt

28. mai 2026

Først innsendt som oppfylte QC-kriteriene

12. juni 2026

Først lagt ut (Faktiske)

17. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AB-10-8012
  • 2025 (U.S. NIH-stipend/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-524159-30-00 (Ctis)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

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. .

Abonnere