RecruitingPhase 2NCT06650852

A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)

A Phase 2 Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and Pegylated Interferon Alpha (PEG-IFNα) in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)

Sponsor

Brii Biosciences Limited

Enrollment

250 participants

Start Date

Oct 31, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Hepatitis B Virus (HBV) Infection

Summary

This Phase 2, randomized, double-blind study will evaluate the clinical efficacy and safety of the combination therapy of BRII-179, BRII-835, plus PEG-IFNα compared to PEG-IFNα in adult participants with chronic HBV infection without cirrhosis receiving neucloes(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria5

Male or female aged 18-60 years.
Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2.
Chronic HBV infection for ≥ 6 months.
On NRTI therapy with HBV DNA \< LLOQ for ≥ 6 months.
Serum ALT and AST ≤ ULN at screening visit.

Exclusion Criteria9

Any clinically significant chronic medical conditions other than chronic HBV infection that makes the participant unsuitable for participation in the study.
Significant liver fibrosis or cirrhosis.
History of clinically significant chronic liver disease from any cause other than chronic HBV infection.
History of hepatic decompensation.
Diagnosed or suspected hepatocellular carcinoma.
Current or past history of infection with HIV, HCV or HDV.
Any laboratory test abnormality that may contradict treatment with PEG-IFNα.
Known history of immunological function impairment.
History of intolerance to intramuscular or subcutaneous injection.

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Interventions

BIOLOGICALBRII-179

BRII-179 will be given via intramuscular injection

DRUGBRII-835 (VIR-2218)

BRII-835 will be given via subcutaneous injection

BIOLOGICALPEG-IFNα

PEG-IFNα will be given via subcutaneous injection

DRUGPlacebo of BRII-179

Placebo of BRII-179 will be given via intramuscular injection

DRUGPlacebo of BRII-835

Placebo of BRII-835 will be given via subcutaneous injection