A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)

Part of paid clinical trials in San Francisco, California.

Sponsor
GlaxoSmithKline
Study ID
NCT06537414
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daplusiran/Tomligisiran Dose Level 1 — DRUG
    Daplusiran/Tomligisiran dose level 1 will be administered
  • Daplusiran/Tomligisiran Dose Level 2 — DRUG
    Daplusiran/Tomligisiran dose level 2 will be administered
  • Bepirovirsen — DRUG
    Bepirovirsen will be administered
  • Placebo — DRUG
    Placebo will be administered

Study Details

The study is intended to evaluate the efficacy and safety of 2 different doses of DAP/TOM followed by bepirovirsen in participants living with CHB on standard of care nucleos(t)ide analogue (NA) therapy. The study also aims to identify an optimal dose of DAP/TOM for sequenced therapy with bepirovirsen for further clinical development and to assess the contribution of DAP/TOM to the sequential regimen.

Key Dates

Start date
Nov 11, 2024
Status verified
Jul 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
283 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm 1A: DAP/TOM + Bepirovirsen
    Participants with high Hepatitis B surface antigen (HBsAg) level will receive dose level 1 of DAP/TOM in Treatment Stage 1. After DAP/TOM Treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment.
  • Experimental: Treatment Arm 1B: DAP/TOM + Bepirovirsen
    Participants with high HBsAg level will receive dose level 2 of DAP/TOM in Treatment Stage 1. After DAP/TOM treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment.
  • Experimental: Treatment Arm 2A: DAP/TOM + Bepirovirsen
    Participants with low HBsAg level will receive dose level 1 of DAP/TOM in Treatment Stage 1. After DAP/TOM treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment.
  • Experimental: Treatment Arm 2B: DAP/TOM + Bepirovirsen
    Participants with low HBsAg level will receive dose level 2 of DAP/TOM in Treatment Stage 1. After DAP/TOM treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment.
  • Experimental: Treatment Arm 2C: Placebo + Bepirovirsen
    Participants with low HBsAg level will receive Placebo in Treatment Stage 1. After Placebo treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment.

Primary Outcome Measure

Number of participants achieving functional cure [ Time Frame: Up to 100 Weeks ]

Locations (5)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteSan FranciscoCalifornia94115-
GSK Investigational SiteSan JoseCalifornia95128-
GSK Investigational SiteMinneapolisMinnesota55415-
GSK Investigational SiteNew YorkNew York10029-
GSK Investigational SitePhiladelphiaPennsylvania19104-

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