AuthorisedTherapeutic exploratory (Phase II)Interventional

TARGET-EBV in MS: A prospective randomized controlled parallel group phase 2b double blinded study to investigate if targeting Epstein Barr Virus with Tenofovir Alafenamide Fumarate compared to placebo as add-on treatment to anti-CD20 therapy reduces neuronal damage in multiple sclerosis

This research, called TARGET-EBV in MS, is a study for people with multiple sclerosis (MS). It's looking at whether an existing drug, Tenofovir Alafenamide, can help slow down nerve damage when added to a common MS treatment that targets special immune cells. The drug is thought to work by aiming at the Epstein-Barr virus, which some scientists believe might play a role in MS. Participants will either receive the active drug or a dummy pill (placebo) alongside their usual anti-CD20 therapy. Researchers will measure changes in specific markers in the fluid around the brain and spinal cord to see if the treatment makes a difference over 52 weeks.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Oslo University Hospital HF

Enrolment target

Start

11 Aug 2025

multiple sclerosis

What is this study about?

This study, called TARGET-EBV in MS, is exploring a new way to potentially protect the brain and spinal cord in people living with multiple sclerosis (MS). We know that MS causes damage to nerve cells, which can lead to various symptoms. Researchers are particularly interested in the Epstein-Barr virus (EBV), a very common virus, as some science suggests it might be linked to MS progression. This trial aims to see if targeting EBV could help reduce nerve damage.

Participants in the study will be given an additional treatment on top of their usual MS medication, which targets specific immune cells (called anti-CD20 therapy). Half of the participants will receive a drug called Tenofovir Alafenamide, which is already used for other viral infections and may also affect EBV. The other half will receive a dummy pill (placebo). This is a 'blinded' study, meaning neither the patients nor their doctors will know who is getting the active drug and who is getting the placebo, to ensure fair results. The main goal is to see if the drug can lower a specific marker of nerve damage in the fluid surrounding the brain and spine.

By carefully comparing the group receiving the active drug to the group receiving the placebo over 52 weeks, the researchers hope to understand if Tenofovir Alafenamide can help slow down the damage to nerve cells. This could potentially lead to new and more effective treatments for MS in the future, improving the quality of life for people with the condition. The results of this study will help us learn more about the role of EBV in MS and whether targeting it is a promising approach.

Key takeaways

The study investigates if a drug called Tenofovir Alafenamide can reduce nerve damage in MS.
It aims to target the Epstein-Barr virus, which may be connected to MS.
Participants will receive either the active drug or a placebo alongside their regular MS treatment.
The research lasts for about one year (52 weeks) and involves several clinic visits.
Measurements will include markers in spinal fluid, brain scans, and fatigue questionnaires.
The goal is to find new ways to protect nerves and improve MS treatment.

Who may be eligible?

This study is looking for adults who have multiple sclerosis. You would need to be 18 years old or older to take part.

You would also be currently receiving an MS treatment that targets specific immune cells (this is called anti-CD20 therapy). The research team will check all your medical details to make sure this study is right for you and that taking part would be safe.

The research team will have a full list of things that would allow you to join the study, and also things that might mean you couldn't take part. This ensures the study includes the right people to get clear results and keep everyone safe.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of multiple sclerosis?
Are you currently receiving an 'anti-CD20' type of MS treatment?
Are you willing and able to attend study visits and follow the study plan for about a year?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would be involved for about 52 weeks (just under a year). During this time, you would continue to receive your usual anti-CD20 MS treatment. On top of this, you would be given either the study drug, Tenofovir Alafenamide, or a dummy pill (placebo) in capsule form to take regularly.

You would need to attend several visits to the study clinic. These visits would involve various assessments, such as giving blood samples, providing samples of the fluid around your brain and spinal cord (lumbar punctures), and having special scans like PET scans to look at inflammation in your brain. You would also be asked to complete questionnaires about how you are feeling, including any fatigue. The research team would keep a close eye on your health and any side effects you might experience throughout the study.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and potential risks. You might benefit from closer monitoring of your MS and potentially receive a treatment that could help reduce nerve damage. However, there's no guarantee the study drug will work for you, and you might receive the placebo. Potential risks could include side effects from the study medication or the procedures involved, like regular blood tests and lumbar punctures, though all procedures are carried out by experienced medical staff. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Norway

Common questions

What is Epstein-Barr Virus (EBV)?

EBV is a very common virus that most people catch at some point, often causing no symptoms or mild illness like glandular fever. Some research suggests it might be linked to conditions like MS.

What is 'nerve damage' in MS?

In MS, the body's immune system mistakenly attacks the protective covering of nerves. This damage can make it harder for nerves to send signals, leading to MS symptoms.

What is a 'dummy pill' (placebo)?

A dummy pill (placebo) looks exactly like the study drug but contains no active medicine. It helps researchers know if the effects they see are truly from the drug or something else.

What is anti-CD20 therapy?

Anti-CD20 therapy is a type of MS treatment that targets and reduces certain immune cells called B cells, which are thought to play a role in MS-related inflammation.

Will I know if I'm getting the active drug or the dummy pill?

No, this is a 'blinded' study. Neither you nor your doctor will know if you are receiving the active drug or the dummy pill until after the study has finished and the results are analysed.