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)
Overview
- Phase
- Phase 2
- Intervention
- BRII-179
- Conditions
- Not specified
- Sponsor
- Brii Biosciences Limited
- Enrollment
- 250
- Locations
- 14
- Primary Endpoint
- Percentage of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female aged 18-60 years.
- •Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m
- •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.
Arms & Interventions
Regimen 1: BRII-179 + BRII-835 + PEG-IFNα
Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 1).
Intervention: BRII-179
Regimen 1: BRII-179 + BRII-835 + PEG-IFNα
Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 1).
Intervention: BRII-835 (VIR-2218)
Regimen 1: BRII-179 + BRII-835 + PEG-IFNα
Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 1).
Intervention: PEG-IFNα
Placebo of BRII-179 + Placebo of BRII-835 + PEG-IFNα
Participants will receive placebo of BRII-179, placebo of BRII-835 and PEG-IFNα.
Intervention: PEG-IFNα
Placebo of BRII-179 + Placebo of BRII-835 + PEG-IFNα
Participants will receive placebo of BRII-179, placebo of BRII-835 and PEG-IFNα.
Intervention: Placebo of BRII-179
Placebo of BRII-179 + Placebo of BRII-835 + PEG-IFNα
Participants will receive placebo of BRII-179, placebo of BRII-835 and PEG-IFNα.
Intervention: Placebo of BRII-835
Regimen 2: BRII-179 + BRII-835 + PEG-IFNα
Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 2).
Intervention: BRII-179
Regimen 2: BRII-179 + BRII-835 + PEG-IFNα
Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 2).
Intervention: BRII-835 (VIR-2218)
Regimen 2: BRII-179 + BRII-835 + PEG-IFNα
Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 2).
Intervention: PEG-IFNα
Outcomes
Primary Outcomes
Percentage of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Time Frame: Up to 96 weeks
The percentage of participants achieving HBsAg seroclearance.
Time Frame: Up to 48 weeks
Secondary Outcomes
- Percentage of participants achieving HBsAg seroclearance.(Up to 72 weeks)
- Percentage of participants achieving functional cure.(Up to 96 weeks)
- Percentage of participants achieving HBsAg seroconversion.(Up to 72 weeks)