GSK3965193 for Hepatitis B
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called GSK3965193 for individuals with long-term hepatitis B. The goal is to determine if this drug can safely reduce the hepatitis B virus in the body and improve health outcomes. Some participants will take the drug alone, while others will combine it with another treatment, bepirovirsen, to assess if the combination is more effective. The trial seeks individuals who have had chronic hepatitis B for at least six months and are currently on stable hepatitis B medication. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, participants in Parts 3 and 4 must be on stable NA therapy (like tenofovir or entecavir), so you may need to continue those medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that bepirovirsen is generally safe and well-tolerated in people with chronic hepatitis B. For instance, a Phase 2b study tested bepirovirsen for 12 to 24 weeks and found it safe for those already on stable hepatitis B treatments. Larger studies are ongoing to confirm its safety and effectiveness.
GSK3965193 is undergoing its first tests in humans. In these early trials, researchers closely monitor for side effects and test different doses to determine the safest and most effective amount. As this is a Phase 1/2a study, the primary goal is to ensure GSK3965193's safety before proceeding to larger studies.
Overall, while earlier studies have shown bepirovirsen's safety, GSK3965193 remains new in human testing. Participants are closely monitored to ensure their safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about GSK3965193 for Hepatitis B because it offers a novel approach compared to existing treatments like nucleos(t)ide analogs and interferon therapies. Unlike most treatments that typically focus on suppressing the virus, GSK3965193 is designed to work in fasted conditions and is being tested in various dosing regimens, potentially allowing for more flexible and tailored treatment options. Additionally, the treatment is being explored in combination with bepirovirsen, which could enhance its effectiveness by targeting the virus through a complementary mechanism. This multi-faceted strategy could lead to improved outcomes for patients with Hepatitis B, offering hope for more effective and efficient management of the condition.
What evidence suggests that this trial's treatments could be effective for hepatitis B?
Research has shown that bepirovirsen, which participants in this trial may receive, has potential in treating hepatitis B. In earlier studies, up to 29% of patients had no detectable virus levels after 24 weeks of treatment with bepirovirsen. This treatment stops the virus from replicating and reduces its presence in the blood. GSK3965193, another treatment option in this trial, is still under investigation for its effectiveness, but researchers will test its ability to lower hepatitis B virus levels. Although GSK3965193 is new, combining it with bepirovirsen is based on encouraging early results.23678
Who Is on the Research Team?
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18-55 and those with chronic hepatitis B aged 18-65, who are not pregnant or breastfeeding and use effective contraception. Participants must weigh at least 50 kg with a BMI of 18-32 kg/m^2. For parts involving patients with hepatitis, they must have been diagnosed over six months ago and be on stable antiviral therapy.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Single ascending doses of GSK3965193 and placebo in healthy participants with a minimum of 7 days washout between dosing in each period
Treatment Part 2
Repeat doses of GSK3965193 or placebo in healthy participants, starting at least 3-fold below the highest dose completed in Part 1
Treatment Part 3
GSK3965193 to lower hepatitis B virus surface antigen in participants with chronic hepatitis B, with optional open label bepirovirsen for 24 weeks
Treatment Part 4
Combination therapy with GSK3965193 and bepirovirsen to evaluate safety and potential sustained virologic response in participants with chronic hepatitis B
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bepirovirsen
- GSK3965193
Trial Overview
The study tests GSK3965193's safety, tolerability, and pharmacokinetics in healthy individuals (Parts 1 & 2) and its effect on lowering the hepatitis B surface antigen in infected participants (Part 3). Part 4 explores combining GSK3965193 with bepirovirsen to achieve sustained virologic response in those infected.
How Is the Trial Designed?
18
Treatment groups
Experimental Treatment
Placebo Group
PLWCHB on stable NA therapy were planned to receive placebo oral tablets plus bepirovirsen SC injection for 28 days. All participants were further planned to continue receiving bepirovirsen SC injection after 28 days.
PLWCHB on stable NA therapy were planned to receive GSK3965193 oral tablets plus bepirovirsen SC injection for 28 days. All participants were further planned to continue receiving bepirovirsen SC injection after 28 days.
PLWCHB on stable NA therapy received repeat doses of GSK3965193 Dose 9 oral tablets for 28 days. Participants who completed GSK3965193 monotherapy were given the option to receive subsequent treatment of optional open label bepirovirsen SC injection from Day 43. Dose 9 of GSK3965193 was higher than Dose 4 but lower than Dose 5.
Healthy participants received GSK3965193 Dose 10 oral tablets under fed condition in Treatment Period 1, followed by GSK3965193 Dose 10 oral tablets under fasted condition in Treatment Period 2. Dose 10 of GSK3965193 was higher than Dose 5 but lower than Dose 6.
Healthy participants received GSK3965193 Dose 10 oral tablets under fasted condition in Treatment Period 1, followed by GSK3965193 Dose 10 oral tablets under fed condition in Treatment Period 2. Dose 10 of GSK3965193 was higher than Dose 5 but lower than Dose 6.
Healthy participants received repeat doses of GSK3965193 Dose 9 oral solution BID for 14 days. Dose 9 of GSK3965193 was higher than Dose 4 but lower than Dose 5.
Healthy participants received repeat doses of GSK3965193 Dose 6 oral solution BID for 14 days. Dose 6 of GSK3965193 was higher than Dose 10 but lower than Dose 7.
Healthy participants received repeat doses of GSK3965193 Dose 5 oral solution BID for 14 days. Dose 5 of GSK3965193 was higher than Dose 9 but lower than Dose 10.
Healthy participants received a single dose of placebo oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 6 oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 7 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 8 oral solution on Day 1 in Treatment Period 4. Dose 8 of GSK3965193 was higher than Dose 7 and Dose 7 was higher than Dose 6.
Healthy participants received a single dose of GSK3965193 Dose 5 oral solution on Day 1 in Treatment Period 1; followed by a single dose of placebo oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 7 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 8 oral solution on Day 1 in Treatment Period 4. Dose 8 of GSK3965193 was higher than Dose 7 and Dose 7 was higher than Dose 5.
Healthy participants received a single dose of GSK3965193 Dose 5 oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 6 oral solution on Day 1 in Treatment Period 2; followed by a single dose of placebo oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 8 oral solution on Day 1 in Treatment Period 4. Dose 8 of GSK3965193 was higher than Dose 6 and Dose 6 was higher than Dose 5.
Healthy participants received a single dose of GSK3965193 Dose 5 oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 6 oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 7 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of placebo oral solution on Day 1 in Treatment Period 4. Dose 7 of GSK3965193 was higher than Dose 6 and Dose 6 was higher than Dose 5.
Healthy participants received a single dose of placebo oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 2 oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 3 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 4 oral solution on Day 1 in Treatment Period 4. Dose 4 of GSK3965193 was higher than Dose 3 and Dose 3 was higher than Dose 2.
Healthy participants received a single dose of GSK3965193 Dose 1 oral solution on Day 1 in Treatment Period 1; followed by a single dose of placebo oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 3 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 4 oral solution on Day 1 in Treatment Period 4. Dose 4 of GSK3965193 was higher than Dose 3 and Dose 3 was higher than Dose 1.
Healthy participants received a single dose of GSK3965193 Dose 1 oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 2 oral solution on Day 1 in Treatment Period 2; followed by a single dose of placebo oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 4 oral solution on Day 1 in Treatment Period 4. Dose 4 of GSK3965193 was higher than Dose 2 and Dose 2 was higher than Dose 1.
Healthy participants received a single dose of GSK3965193 Dose 1 oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 2 oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 3 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of placebo oral solution on Day 1 in Treatment Period 4. Dose 3 of GSK3965193 was higher than Dose 2 and Dose 2 was higher than Dose 1.
Healthy participants received repeat doses of placebo oral solution twice daily (BID) for 14 days.
Participants living with chronic hepatitis B infection (PLWCHB) on stable nucleos(t)ide analog (NA) therapy received repeat doses of placebo oral tablets for 28 days. Participants who completed placebo monotherapy were given the option to receive subsequent treatment of optional open label bepirovirsen subcutaneous (SC) injection from Day 43.
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Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School
Published Research Related to This Trial
Citations
1.
ir.ionis.com
ir.ionis.com/news-releases/news-release-details/ionis-announces-positive-data-gsks-phase-2b-clinical-studyIonis announces positive data from GSK's Phase 2b clinical ...
Patients with low baseline hepatitis B surface antigen levels responded best to treatment with bepirovirsen with 16% and 25% of patients achieving the primary ...
GSK receives US FDA Fast Track designation for ...
Bepirovirsen inhibits the replication of viral DNA in the body, suppresses the level of hepatitis B surface antigen (HBsAg) in the blood, and ...
3.
ir.ionis.com
ir.ionis.com/news-releases/news-release-details/ionis-announces-presentation-positive-phase-2b-data-chronicIonis announces presentation of positive Phase 2b data for ...
Data from the Phase 2b B-Clear study demonstrated the potential of bepirovirsen to provide rapid reductions in hepatitis B surface antigen in ...
Investigational hepatitis B therapy is granted FDA fast-track ...
In previous data reports, GSK said 28-29% of patients with chronic hepatitis B has achieved undetectable virus levels after 24 weeks of treatment with ...
Efficacy and Safety of Bepirovirsen in Chronic Hepatitis B ...
In this phase 2b trial, bepirovirsen at a dose of 300 mg per week for 24 weeks resulted in sustained HBsAg and HBV DNA loss in 9 to 10% of participants with ...
6.
ir.ionis.com
ir.ionis.com/news-releases/news-release-details/ionis-announces-gsk-has-advanced-bepirovirsen-phase-3Ionis announces GSK has advanced bepirovirsen into ...
GSK has initiated two randomized, double-blind, placebo-controlled Phase 3 studies evaluating the safety and efficacy of bepirovirsen (formerly IONIS-HBV Rx).
Safety, tolerability and antiviral activity of the antisense ...
The primary objective was to assess the safety and tolerability of bepirovirsen in individuals with chronic hepatitis B (CHB) (NCT02981602).
8.
go.drugbank.com
go.drugbank.com/drugs/DB16202/clinical_trials?conditions=DBCOND0083536%2CDBCOND0048745&phase=2&purpose=treatment&status=completedBepirovirsen Completed Phase 2 Trials for Chronic ...
Safety, Tolerability, Pharmacokinetics and Antiviral Activity of IONIS-HBVRx in Treatment-Naïve Patients With Chronic HBV Infection. Bepirovirsen (DB16202) ...
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