Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A controlled phase II clinical trial evaluating the safety and efficacy of myelin peptide-loaded tolDC as treatment for Multiple Sclerosis

This study is for people with multiple sclerosis (MS) and is testing a new treatment called 'tolDC'. We want to find out if this treatment is safe and if it can help slow down the disease. Researchers will use special brain scans (MRIs) to look for new or growing areas of damage, which can happen in MS. We will also check for any side effects and see if the treatment reduces MS flare-ups. The study aims to understand how this new treatment might help people living with MS by looking at various health measures over time.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Antwerp University Hospital

Enrolment target

Start

22 Nov 2024

Multiple Sclerosis

What is this study about?

This study is about a new treatment for Multiple Sclerosis (MS) called 'tolDC'. At the moment, we know that MS is a condition where the body's immune system mistakenly attacks its own protective covering around nerves, called myelin. This new treatment, tolDC, is designed to help calm down this overactive immune response in a very specific way.

The main goal of this study is to see if tolDC is safe to use and if it can help reduce some of the signs of MS activity in the brain. Researchers will be regularly taking special pictures of participants' brains using MRI scans. They will be looking for any new or growing 'lesions' – these are small areas of damage that show up on the scans and indicate MS activity. By counting these, they can get an idea of how well the treatment is working.

Beyond just the brain scans, the study will also keep a close eye on other important things. This includes checking for any side effects (how safe the treatment is), seeing if people have fewer MS flare-ups (relapses), and monitoring their overall physical abilities. Observing all these different aspects will give us a good picture of how tolDC affects people with MS.

Key takeaways

This study is testing a new MS treatment called tolDC.
It's a Phase II study, focusing on safety and early signs of effectiveness.
Researchers will use brain scans to check for new MS activity.
They will also monitor MS flare-ups and overall health.
It's for adults aged 18 and over with an MS diagnosis.

Who may be eligible?

This study is open to both men and women who are 18 years old or older.

However, it's not simply about age and sex. You would need to have a confirmed diagnosis of Multiple Sclerosis.

The research team will have specific medical criteria to make sure the study treatment is suitable and safe for everyone involved. They will ask you about your medical history and current health to check if you meet all the requirements.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of Multiple Sclerosis (MS)?
Are you willing to have regular brain scans (MRIs)?
Are you able to attend regular clinic visits?

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, it would involve regular visits to the study clinic over a period of time. These visits will include various assessments, such as physical examinations, blood tests, and receiving the study treatment, tolDC, which will be given in a specific way determined by the research team. You will also have regular MRI brain scans to monitor any changes.

The team will monitor your health closely throughout the study for any side effects or changes in your MS symptoms. You will be asked about any MS flare-ups and how you are feeling generally. The total duration of your participation will depend on the study plan, but it will involve a follow-up period after the main treatment. The study team will explain the exact schedule and what's involved in detail.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as access to a new treatment (tolDC) that isn't yet widely available, and close monitoring of your MS by a specialist team. However, there are also potential risks, such as experiencing side effects from the treatment, which may not be fully known yet. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

—
Spain
—
Belgium

Common questions

What is 'tolDC'?

TolDC is a new type of treatment being investigated for Multiple Sclerosis. It aims to help calm the immune system in a specific way that targets the disease without affecting the whole body's immunity.

Why are you doing brain scans?

Brain scans (MRIs) help us see what's happening inside your brain. In this study, they're used to check for new or growing areas of damage (lesions) caused by MS, helping us understand if the treatment is working.

What does 'Phase II' mean for a trial?

Phase II means this is an early stage of testing. It's mainly about finding out if the treatment is safe and if it shows encouraging signs of helping people, before larger studies are done.

Will I know if I'm getting the actual treatment or a dummy treatment?

In some studies, participants might not know if they are getting the active treatment or a placebo (inactive treatment) until the study ends. The research team will explain how this study is set up.

What happens if I feel unwell during the study?

The study team will monitor your health very closely. If you feel unwell at any point, you should report it immediately to the study staff who will advise you on what to do and provide necessary care.