Many people living with chronic hepatitis B are hoping for better treatment options, especially medicines that can lead to long-lasting control of the virus. A new research study, called B‑SUPREME, is now enrolling participants to help test a potential new treatment. This study could play an important role in moving HBV research forward.
What Is the B‑SUPREME Study?
B‑SUPREME is a Phase 2 clinical trial. Phase 2 studies focus on learning more about how safe a medicine is and how well it works. The medicine being tested is called ALG‑000184. It is considered investigational, which means it is approved for use in clinical research but is not yet approved for the treatment of chronic hepatitis B infection.
Researchers want to understand how well this study medicine lowers the hepatitis B virus in the blood and how safe the study medicine may be.
Who Can Join the Study?
The study has a few main requirements. Participants must:
- Be between 18 and 65 years old with a diagnosis of chronic hepatitis B infection,
- Have either never received hepatitis B treatment or must not have received hepatitis
B treatment within the last six months before enrolling in the study and - Have never received a capsid assembly modulator (CAM), since previous exposure
could affect study results.
What Does Participation Involve?
If someone qualifies and chooses to join, the entire study lasts about 28 months. That’s a little more than two years. The time is divided into several phases so researchers can understand the medicine from different angles.
The First 48 Weeks
During the first part of the study, participants are randomly assigned to receive either the new study drug, ALG‑000184, or a placebo version of TDF. A placebo looks exactly like real medicine but does not contain any active drug. TDF is a standard treatment for hepatitis B. Using a placebo version helps researchers compare how well the new study drug works.
Everyone takes one pill per day. For the first four weeks, you will visit the study center every two weeks. After that, visits happen once every four weeks until Week 48.
The Next 48 Weeks: Extension Phase
During an extension period of 48 weeks all study participants will take ALG‑000184 only. This part of the study is designed to help researchers learn more about how the medicine works inside the body and how strong its antiviral effects may be.
During this phase, participants return every six to eight weeks until they reach Week 96.
The Long-Term Follow-Up Option
Once participants finish Week 96, they can choose what to do next. One option is to join a long-term follow-up study. This would allow them to continue taking ALG‑000184 for another three to four years. This extra time helps researchers study medicine’s long-term
safety and efficacy.
If someone decides not to continue, that is completely fine. They would have just one final visit at eight weeks after taking their last dose.
Costs, Care, and Support
All study-related medication and tests are free for participants. They will also receive reimbursement for travel/transportation. People can leave the study at any time. If participants experience any study-related side effects, the study team will take good care
of them.
If a participant agrees, their treating doctor can also stay informed of their progress, which
helps ensure that the person receives support if they decide to leave.
Why This Study Matters
Current treatments help many people but they do not work the same for everyone. Some people may still have virus in their body. The B‑SUPREME study explore whether the study medication could be a future treatment option for chronic hepatitis B. By taking part in the study, participants may help improve understanding of hepatitis B and support future research and care for themselves and others.

