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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatitis B, Chronic
• Intervention / Treatment: Drug: AHB-137

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Maggie Davis; Phone Number: (650) 650-2877; Email: ausperbioclinicaltrials@ausperbio.com

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • University of Calgary
• France
  • Clichy, France, 92118
    • Hôpital Beaujon
• Italy
  • Milan, Italy, 20122
    • Clinica Mangiagalli
• Spain
  • Barcelona, Spain, 8035
    • Vall d'Hebron Hospital
• United Kingdom
  • London, United Kingdom, SE5 9RS
    • King's College Hospital
• United States
  • California
    • Palo Alto, California, United States, 94304-1509
      • Stanford University
  • Maryland
    • Baltimore, Maryland, United States, 21201-1009
      • University of Maryland
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health
  • Texas
    • San Antonio, Texas, United States, 78215-2100
      • Texas Liver Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Dose Regimen A; Participants receive AHB-137 according to dosing regimen A.	Drug: AHB-137; Subcutaneous injection
Experimental: Arm B: Dose Regimen B; Participants receive AHB-137 according to dosing regimen B.	Drug: AHB-137; Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ)	24 Weeks post AHB-137 treatment (Week 48)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants that meet nucleos(t)ide analog (NA) discontinuation criteria		Week 48
Proportion of participants with anti-HBs seroconversion (with hepatitis B surface antibody [HBsAb] > 10 IU/L)		Weeks 24, 48, and 72
Proportion of participants who experience virologic relapse		From baseline through Week 72
Area under the plasma concentration-time curve (AUC) of AHB-137		From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Concentration at the end of the dosing interval (Ct) of AHB-137		From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Maximum observed plasma concentration (Cmax) of AHB-137		From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Time to maximum observed plasma concentration (Tmax) of AHB-137		From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Apparent plasma clearance (CL/F) of AHB-137		From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Proportion of participants with HBsAg < LOD and HBV DNA < LLOQ		Off-treatment follow-up (Week 48 to 72)
Proportion of participants with HBsAg < LOD		Week 72
Proportion of participants with HBV DNA < LLOQ		From baseline through Week 72
Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA 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		24 weeks post AHB-137 treatment and at Week 72
Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA		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		From baseline through end of study (Week 72)
Proportion of participants with highly sensitive HBsAg < LOD (0.005 IU/mL)		From baseline through end of study (Week 72)
Proportion of participants with protocol-defined levels of HBsAg		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		From baseline through end of study (Week 72)
Quantitative hepatitis B virologic and serologic markers over time	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		From NA therapy discontinuation (Week 48) through end of follow-up (Week 72)
Change from baseline in alanine aminotransferase (ALT)		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		From baseline through end of study (Week 72)
Proportion of patients with drug-resistant mutations		From baseline through end of study (Week 72)
Proportion of participants with treatment-emergent adverse events (TEAEs)	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		From baseline through end of study (Week 72)
Area Under the Plasma Concentration-Time Curve (AUC) of AHB-137		From first dose (Day 1) through end of study (Week 72)
Plasma Concentration of AHB-137 at the End of the Dosing Interval (Cτ)		From first dose (Day 1) through end of study (Week 72)
Maximum Observed Plasma Concentration (Cmax) of AHB-137		From first dose (Day 1) through end of study (Week 72)
Time to Maximum Observed Plasma Concentration (Tmax) of AHB-137		From first dose (Day 1) through end of study (Week 72)
Apparent Plasma Clearance (CL/F) of AHB-137		From first dose (Day 1) through end of study (Week 72)

Collaborators and Investigators

• Sponsor: AusperBio Therapeutics Inc.
• Investigators: Study Director: Audrey Lau, MD, PhD, AusperBio Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): June 17, 2026
• Primary Completion (Estimated): March 24, 2027
• Study Completion (Estimated): July 26, 2028

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Pathologic Processes; Digestive System Diseases; Virus Diseases; Hepatitis; Hepatitis B; Chronic Hepatitis; Infections; Liver Diseases; DNA Virus Infections; Chronic Disease; Nucleos(t)ide analogue; Chronic Hepatitis B; Hepatitis B Virus; hepatitis B virus e-antigen; Antisense Oligonucleotide; Disease Attributes; Hepatitis B, Chronic; Communicable Diseases; Hepatitis, Viral, Human; Nucleos(t)ide analog; Blood-Borne Infections; Pathological Conditions, Signs and Symptoms; AHB-137
• Additional Relevant MeSH Terms: Hepadnaviridae Infections; Blood-Borne Infections; Digestive System Diseases; Hepatitis; Infections; Communicable Diseases; Liver Diseases; Hepatitis B; Hepatitis B, Chronic; Hepatitis, Chronic; Virus Diseases; DNA Virus Infections; Pathologic Processes; Disease Attributes; Chronic Disease; Pathological Conditions, Signs and Symptoms; Hepatitis, Viral, Human
• Other Study ID Numbers: AB-10-8012; 2025-524159-30-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No