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)

Brii Biosciences

Status and phase: Enrolling; Phase 2

Conditions: Chronic Hepatitis B Virus (HBV) Infection

Treatments: Drug: Placebo of BRII-179; Drug: Placebo of BRII-835; Biological: PEG-IFNα; Drug: BRII-835 (VIR-2218); Biological: BRII-179

Study type: Interventional

Funder types: Industry

Identifiers

NCT06650852

BRII-179-835-003

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 3 patient groups

Regimen 1: BRII-179 + BRII-835 + PEG-IFNα

Experimental group

Description:

Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 1).

Treatment:

Drug: BRII-835 (VIR-2218)

Biological: BRII-179

Biological: PEG-IFNα

Placebo of BRII-179 + Placebo of BRII-835 + PEG-IFNα

Active Comparator group

Description:

Participants will receive placebo of BRII-179, placebo of BRII-835 and PEG-IFNα.

Treatment:

Biological: PEG-IFNα

Drug: Placebo of BRII-835

Drug: Placebo of BRII-179

Regimen 2: BRII-179 + BRII-835 + PEG-IFNα

Experimental group

Description:

Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 2).

Treatment:

Drug: BRII-835 (VIR-2218)

Biological: BRII-179

Biological: PEG-IFNα