Approval Probability
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Daplusiran/Tomligisiran Dose Level 1 · 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 Dose Level 1 is an investigational small molecule being developed for the treatment of chronic hepatitis B virus infection. It is currently in Phase 2 clinical development and is being studied as part of a sequential therapy regimen followed by bepirovirsen in participants living with chronic hepatitis B.
Daplusiran/Tomligisiran Dose Level 1 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting a Phase 2 clinical trial to evaluate the drug in patients with chronic hepatitis B virus infection.
Daplusiran/Tomligisiran Dose Level 1 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is active but not recruiting participants, with a planned enrollment of 283 patients.
Daplusiran/Tomligisiran Dose Level 1 is being evaluated in a Phase 2 clinical trial registered as NCT06537414. The study is titled 'A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)' and is active but not recruiting.
Yes, Daplusiran/Tomligisiran Dose Level 1 is also known as DAP/TOM. The clinical trial NCT06537414 refers to the drug as Daplusiran/Tomligisiran (DAP/TOM), indicating that DAP/TOM is an abbreviated name for the same investigational therapy.