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Daplusiran/Tomligisiran · 1 trial · 2 indications
The functional cure for HBV is defined as sustained suppression (24 weeks or longer) of HBV deoxyribonucleic acid (DNA) \<lower limit of quantification (LLOQ) and HBsAg not detected with or without HBsAb after a finite duration of therapy and off all HBV treatment. The number of participants achieving functional cure after discontinuation of all chronic HBV treatments (DAP/TOM, bepirovirsen, and NA treatment) will be reported.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm 1A: DAP/TOM + Bepirovirsen | EXPERIMENTAL | 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. |
| Treatment Arm 1B: DAP/TOM + Bepirovirsen | EXPERIMENTAL | 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. |
| Treatment Arm 2A: DAP/TOM + Bepirovirsen | EXPERIMENTAL | 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. |
| Treatment Arm 2B: DAP/TOM + Bepirovirsen | EXPERIMENTAL | 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. |
| Treatment Arm 2C: Placebo + Bepirovirsen | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| 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 |
Inclusion Criteria: * Age: At least 18 years of age at the time of signing the informed consent * Documented chronic HBV infection greater than or equal to (\>=) 6 months prior to Screening AND currently receiving stable NA therapy defined as receiving an NA regimen form at least 6 months prior to ...
Daplusiran/Tomligisiran is an investigational RNA therapy being developed for chronic hepatitis B virus infection. It is a small interfering RNA (siRNA) combination, and it is currently in Phase 2 clinical development. It is being studied as part of a sequential treatment approach in adults living with chronic hepatitis B.
Daplusiran/Tomligisiran is being studied for the treatment of chronic hepatitis B virus infection in adults. The Phase 2 trial evaluates it as sequential therapy followed by bepirovirsen in participants living with chronic hepatitis B. It is investigational and has not been approved for any indication.
Daplusiran/Tomligisiran is a small interfering RNA (siRNA) therapy. siRNA agents are designed to interfere with the expression of specific RNA targets. The drug is being developed as a combination siRNA approach for chronic hepatitis B virus infection, and it is given before bepirovirsen in the sequential regimen under study.
Daplusiran/Tomligisiran is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the Phase 2 study evaluating the siRNA combination as sequential therapy followed by bepirovirsen in people living with chronic hepatitis B.
Daplusiran/Tomligisiran is in Phase 2 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The single registered trial is a Phase 2 study that is currently active but no longer recruiting participants.
Daplusiran/Tomligisiran is being evaluated in one Phase 2 trial, NCT06537414, titled a study of sequential therapy with Daplusiran/Tomligisiran followed by bepirovirsen in participants living with chronic hepatitis B. The trial has enrolled 283 participants, is randomized, double blind, and controlled, and is active but not recruiting.