Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic HBV Infection

Study Overview
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Brief Summary
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This is an open label, randomized, parallel-group study to evaluate the safety and efficacy of combination treatment BRII-835 (VIR-2218) and BRII-179 (VBI-2601) in adult participants with chronic HBV infection

Official Title
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A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of BRII-835 (VIR-2218) and BRII-179 (VBI-2601) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Drug: BRII-835 (VIR-2218)
* Biological: BRII-179 (VBI-2601) with IFN-α
* Biological: BRII-179 (VBI-2601)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 18 - 60 Body mass index ≥ 18 kg/m^2 and ≤ 32 kg/m^2 Chronic HBV infection as defined by a positive serum HBsAg for ≥ 6 months Exclusion Criteria: Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation Significant fibrosis or cirrhosis History or evidence of drug or alcohol abuse History of intolerance to SC or IM injection History of chronic liver disease from any cause other than chronic HBV infection History of hepatic decompensation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A<br>Participants will receive BRII-835 (VIR-2218) for 32 weeks | Drug: BRII-835 (VIR-2218)<br>* BRII-835 (VIR-2218) will be given by subcutaneous injection<br>|
| Experimental: Cohort B<br>Participants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40 | Drug: BRII-835 (VIR-2218)<br>* BRII-835 (VIR-2218) will be given by subcutaneous injection<br>Biological: BRII-179 (VBI-2601) with IFN-α<br>* BRII-179 (VBI-2601) with IFN-α will be co-administered by intramuscular injection<br>|
| Experimental: Cohort C<br>Participant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40 | Drug: BRII-835 (VIR-2218)<br>* BRII-835 (VIR-2218) will be given by subcutaneous injection<br>Biological: BRII-179 (VBI-2601)<br>* BRII-179 (VBI-2601) will be administered by intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with sustained HBsAg loss during the 48-week follow-up period after NrtI withdrawal |  | up to Week 96 | 
| Number of participants with Adverse Events (AE) |  | up to Week 96 | 
| Number of participants with Serious Adverse Events (SAE) |  | up to Week 96 | 
| Number of participants with abnormalities in clinical laboratory tests |  | up to Week 96 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis