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

24 augusti 2026 uppdaterad 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).

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

70

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Frankrike
      • Clichy, Frankrike, 92118
        • Har inte rekryterat ännu
        • Hopital Beaujon
  • Förenta staterna
    • California
      • Palo Alto, California, Förenta staterna, 94304-1509
        • Har inte rekryterat ännu
        • Stanford University
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21201-1009
        • Har inte rekryterat ännu
        • University of Maryland
    • New York
      • New York, New York, Förenta staterna, 10016
        • Har inte rekryterat ännu
        • NYU Langone Health
    • Texas
      • San Antonio, Texas, Förenta staterna, 78215-2100
        • Rekrytering
        • Texas Liver Institute
  • Italien
    • Milan
      • Milan, Milan, Italien, 20122
        • Har inte rekryterat ännu
        • Clinica Mangiagalli
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2N 4N1
        • Har inte rekryterat ännu
        • University Of Calgary
    • Ontario
      • Toronto, Ontario, Kanada, M5G 2C4
        • Har inte rekryterat ännu
        • Toronto General Hospital
  • Spanien
    • Barcelona
      • Barcelona, Barcelona, Spanien, 8035
        • Har inte rekryterat ännu
        • Vall d'Hebron Hospital
  • Storbritannien
    • London
      • London, London, Storbritannien, SE5 9RS
        • Har inte rekryterat ännu
        • King's College Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Arm A: Dose Regimen A
Participants receive AHB-137 according to dosing regimen A.
Läkemedel: AHB-137
Subkutan injektion
Experimentell: Arm B: Dose Regimen B
Participants receive AHB-137 according to dosing regimen B.
Läkemedel: AHB-137
Subkutan injektion

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Andel deltagare som uppfyller kriterierna för avslut av nukleos(t)idanalog (NA)-behandling
Tidsram: Vecka 48
Vecka 48
Andel deltagare med anti-HBs serokonvertering (med hepatit B yt-antikropp [HBsAb] > 10 IE/L)
Tidsram: Vecka 24, 48 och 72
Vecka 24, 48 och 72
Andel deltagare som upplever virologisk återfall
Tidsram: Från baslinjen till och med vecka 72
Från baslinjen till och med vecka 72
Area under the plasma concentration-time curve (AUC) of AHB-137
Tidsram: Från första dosen (Dag 1) till slutet av farmakokinetisk provtagning (Vecka 48)
Från första dosen (Dag 1) till slutet av farmakokinetisk provtagning (Vecka 48)
Koncentration vid slutet av doseringsintervallet (Ct) för AHB-137
Tidsram: Från första dosen (dag 1) till slutet av farmakokinetisk provtagning (vecka 48)
Från första dosen (dag 1) till slutet av farmakokinetisk provtagning (vecka 48)
Maximal observerad plasmakoncentration (Cmax) av AHB-137
Tidsram: Från första dosen (dag 1) till slutet av farmakokinetisk provtagning (vecka 48)
Från första dosen (dag 1) till slutet av farmakokinetisk provtagning (vecka 48)
Tid till maximal observerad plasmakoncentration (Tmax) för AHB-137
Tidsram: Från första dosen (dag 1) till slutet av farmakokinetisk provtagning (vecka 48)
Från första dosen (dag 1) till slutet av farmakokinetisk provtagning (vecka 48)
Uppenbar plasmaklaring (CL/F) av AHB-137
Tidsram: Från första dosen (dag 1) till slutet av farmakokinetisk provtagning (vecka 48)
Från första dosen (dag 1) till slutet av farmakokinetisk provtagning (vecka 48)
Proportion of participants with HBsAg < LOD and HBV DNA < LLOQ
Tidsram: Off-treatment follow-up (Week 48 to 72)
Off-treatment follow-up (Week 48 to 72)
Proportion of participants with HBsAg < LOD
Tidsram: Week 72
Week 72
Proportion of participants with HBV DNA < LLOQ
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: From baseline through end of study (Week 72)
From baseline through end of study (Week 72)
Proportion of patients with drug-resistant mutations
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: From first dose (Day 1) through end of study (Week 72)
From first dose (Day 1) through end of study (Week 72)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AusperBio Therapeutics Inc.

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

27 augusti 2026

Primärt slutförande (Beräknad)

11 maj 2027

Avslutad studie (Beräknad)

26 juli 2028

Studieregistreringsdatum

Först inskickad

28 maj 2026

Först inskickad som uppfyllde QC-kriterierna

12 juni 2026

Första postat (Faktisk)

17 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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