A phase 2, single-blinded, randomised, controlled multi-country study to evaluate the safety, reactogenicity, efficacy and immune response following sequential treatment with an anti-sense oligonucleotide (ASO) against chronic Hepatitis B (CHB) followed by chronic Hepatitis B targeted immunotherapy (CHB-TI) in CHB patients receiving nucleos(t)ide analogue (NA) therapy.

Chronic, Hepatitis B

"Safety • Percentage of participants reporting any grade 3 AE from first dose of GSK3228836 up to the study end. • Percentage of participants reporting any SAE from first dose of GSK3228836 up to the study end ", "• Percentage of participants reporting any AESIs grade 3 or higher from first dose of GSK3228836 up to the study end. ", "Efficacy • Percentage of participants who achieve SVR (HBsAg , • Difference between treatment arms (corresponding GSK3228836 regimens) in percentage of participants who achieve SVR (HBsAg < LLOQ and HBV DNA

"Solicited events post GSK3528869A • Percentage of participants reporting each injection site solicited adverse event (injection site redness, pain and swelling) within 7 days (Day 1 – Day 7) post administration of each dose of study treatment ", "• Percentage of participants reporting each systemic solicited adverse event within 7 days (Day 1 – Day 7) post administration of each dose of study treatment. ", "Unsolicited AEs • Percentage of participants reporting any unsolicited AE within 30 days (Day 1 – Day 30) post administration of each dose of GSK3528869A. ", "• Percentage of participants reporting any AE from first dose of GSK3228836 up to study end • Percentage of participants reporting any AESIs from first dose of GSK3228836 up to study end ", "pIMDs • Percentage of participants reporting any pIMDs anytime from first dose of GSK3528869A up to study end. ", "Safety laboratory assessments • Percentage of participants reporting haematological, biochemical or urinalysis laboratory abnormalities anytime from first dose of GSK3228836 up to the study end. ", "Efficacy • qHBsAg: number of participants with ≥0.5 log decrease, ≥1-log decrease, HBsAg loss and log-changes from baseline. • Number of participants with HBsAg loss and anti-HBs seroconversion. • Mean qHBsAg. ", "• Duration of SVR o Time to the first occurrence of HBsAg reversion. o Time to the first occurrence of HBV DNA reversion. ", "• Virologic breakthrough: HBV DNA ≥ 1-log increase from nadir or HBV DNA becoming quantifiable after being below the LLOQ. ", "Immunogenicity • Immunogenicity with respect to HBV components of GSK3528869A, at pre-defined time points. o Anti-HBc antibodies: responder rates and concentration ", "o Anti-HBs antibodies: seroconversion4, responder rates and concentration; anti-HBs ≥10 mIU/mL and ≥100 mIU/mL o Frequency of HBc- and HBs- specific CD4+ T-cell and CD8+ T-cell; CD4+ T-cells responders, CD8+ T-cell responders."

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