Study 217023 bepirovirsen followed by targeted immunotherapy
18 evidence topics · 3 sources
Objective
Basis for combining HBsAg reduction with therapeutic immunization
“Therapeutic vaccines likely require combination therapy for success.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote
“For example, pretreatment with agents that reduce HBsAg before therapeutic immunization and/or concurrent treatment with checkpoint inhibitors or other immune-activating agents might improve efficacy.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote
Location and study date
Study dates and status in the registry record
| Field | Registry entry |
|---|---|
| Recruitment status | “Completed” |
| Study start (actual) | “2022-03-22” |
| Primary completion (actual) | “2025-08-05” |
| Study completion (actual) | “2025-08-05” |
| First posted | “2022-03-11” |
| Last update posted | “2025-12-30” |
Number of study locations
Study design
Phase 2, single-blinded, randomized, controlled design
Design details in the registry record
| Field | Registry entry |
|---|---|
| Allocation | “Randomized” |
| Interventional model | “Sequential Assignment” |
| Masking description | “Open-label for Treatment 1 and single-blinded for Treatment 2.” |
| Phase | “Phase 2” |
| Other study identifiers | “217023” |
| EudraCT number | “2021-003567-10” |
| EU trial number | “2024-512352-38-00” |
Eligibility criteria
Key inclusion criteria
Key exclusion criteria: cirrhosis definitions and laboratory thresholds
Treatment
Bepirovirsen (GSK3228836) dosing in treatment 1
Targeted immunotherapy (GSK3528869A) or control in treatment 2
Four treatment groups
Study outcomes
Rationale for using grade 3 adverse events, serious adverse events, and sustained virologic response as the primary endpoints
Registered primary safety outcomes
Registered primary efficacy outcome: sustained virologic response
Reactogenicity of the immunotherapy regimen given alone in an earlier trial
“Grade 3 solicited adverse events (AEs) (median duration: 2–3 days) were more frequent after co-administration (systemic: 59.3%; administration-site: 33.3%) than sequential administration (systemic: 10.3%; administration-site: 12.8%) of high-dose viral vectors and proteins. No vaccine-related or fatal serious AEs were reported. After 4 doses, no participant had HBsAg loss or ≥1-log decrease in qHBsAg (D337 vs. D1).” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote
Statistical analysis description
Number of participants (Planned and analyzed)
Enrollment in the registry record
| Field | Registry entry |
|---|---|
| Enrollment (actual) | “174” |
Description of analysis sets
No evidence found.
Results
Participant disposition
No evidence found.
Baseline characteristics
No evidence found.
Efficacy results
No evidence found.
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
No evidence found.
Study limitations
Summary: study limitations
Study 217023 enrolled 174 participants and was completed in August 2025; the sponsor submitted results to ClinicalTrials.gov on 2026-08-04, but no results are posted and no publication was identified, so its safety and efficacy outcomes cannot be assessed. The bepirovirsen regimens in this study (12 or 24 weeks with loading doses on days 4 and 11) were followed by an investigational immunotherapy or a non-active control, and only the 24-week regimen corresponds to the approved treatment duration. The follow-up period was reduced from 2 years to at least 1 year after the last dose during the study, and the immunotherapy regimen given alone produced no HBsAg loss in an earlier trial.
Results submitted but not posted
| Field | Registry entry |
|---|---|
| Results submitted to ClinicalTrials.gov | “2026-08-04” |