Active not recruitingPHASE3INTERVENTIONAL

Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis

This research study is looking at a new tablet called IMU-838 for adults aged 18 to 55 who have a type of multiple sclerosis (MS) known as relapsing MS. This includes both relapsing-remitting MS and active secondary progressive MS. The main goal is to find out if IMU-838 can help manage MS symptoms, whether it's safe to use, and if people can comfortably take it, compared to a placebo (a dummy tablet that looks the same but contains no active medicine). The study will run for about 15 months, with some people continuing on the treatment for much longer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Immunic AG

Enrolment target

1,100

Start

12 Jan 2022

Estimated completion

01 Oct 2033

Multiple Sclerosis, Relapsing-Remitting

What is this study about?

This study is a clinical trial, which means it's a carefully planned research project to test a new medicine in people. The medicine being tested is an experimental tablet called IMU-838. It's hoped that this tablet might help slow down the progression of multiple sclerosis (MS) and reduce the number of relapses people experience.

MS is a condition that affects your brain and spinal cord, leading to a range of symptoms. In relapsing MS, people have periods of new or worsening symptoms (relapses) followed by periods of recovery. This study is focusing on adults with this type of MS. By comparing IMU-838 to a placebo, the researchers can clearly see any effects the new medicine has, both good and bad.

Taking part in a study like this is important because it helps scientists find new and better ways to treat conditions like MS. Every approved medicine we have today went through similar studies. It's a way for people to potentially access new treatments that aren't yet widely available, while also contributing to medical knowledge.

Key takeaways

Tests new tablet (IMU-838) for relapsing MS.
Compares IMU-838 to a dummy tablet (placebo).
Study lasts over 15 months, with possible longer-term treatment.
Aims to check if IMU-838 is effective, safe, and well-tolerated.
Involves adults aged 18-55 with recent MS activity.
Your participation is voluntary, and you can stop at any time.

Who may be eligible?

To join this study, you would need to be an adult between 18 and 55 years old, and you must have received a clear diagnosis of multiple sclerosis (MS).

Specifically, the study is looking for people with "relapsing MS." This means you've had recent MS activity, such as at least one relapse in the last year, two relapses in the last two years, or an MRI scan showing new MS activity within the last year. You wouldn't be able to join if you have certain other types of MS, like primary progressive MS.

There are also some other reasons you might not be able to join. For example, if you have other serious health conditions, especially other active autoimmune diseases (though type 1 diabetes and inflammatory bowel disease might be exceptions). You also can't have taken experimental drugs or been in other drug studies recently, or used certain other MS treatments or specific medications. You'd also need to be willing to follow all the study instructions and give your informed consent.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 55 years old?
Do you have a clear diagnosis of MS, specifically a relapsing form?
Have you had recent MS activity (like a relapse or new MRI changes)?
Are you able to attend regular study appointments and follow instructions?
Have you avoided certain other MS treatments or experimental drugs recently?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve several steps. First, there's a screening period of about 28 days to make sure you're a good fit for the study. During this time, you'll have various checks and tests.

After screening, you'll enter the 'Main Treatment Period,' which lasts for about 15 months (72 weeks). During this time, you'll either receive the IMU-838 tablet or a placebo tablet. You, and your study doctor, won't know which one you're getting – this is called 'double-blinded.' You'll have regular visits to monitor your health, how you're feeling, and any changes in your MS.

After the main treatment period, there's an 'Open Label Extension Period.' This can last for up to 8 years. In this part, all participants will know they are receiving the IMU-838 tablet. Throughout the entire study, you'll have follow-up appointments and tests to track your progress and safety. The study team will provide all medication and care related to the study.

Potential risks and benefits

Taking part in a clinical trial could offer the potential benefit of accessing a new treatment (IMU-838) before it's widely available, which might help manage your MS. You'd also receive close medical monitoring. However, there are always potential risks with any new medicine; these could include side effects from the IMU-838 or potential discomfort from study procedures like blood tests. It's important to remember you might receive a placebo and not the active drug during the main part of the study. Your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (76)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Neuro of Central Florida
Verified postcode
Altamonte Springs, United States
Healthcare Innovations
Verified postcode
Coral Springs, United States
Heratsi Hospital Complex 1
Verified postcode
Yerevan, Armenia
Saint Gregory the Illuminator Medical Center
Verified postcode
Yerevan, Armenia
Erebouni Medical Center
Verified postcode
Yerevan, Armenia
UCC of Rep of Srpska
Verified postcode
Banja Luka, Bosnia and Herzegovina
Cantonal Hospital Bihac Dr. Irfan Ljubijankic
Verified postcode
Bihać, Bosnia and Herzegovina
University Clinical Center of Sarajevo
Verified postcode
Sarajevo, Bosnia and Herzegovina
University Clinical Center Sarajevo
Verified postcode
Sarajevo, Bosnia and Herzegovina
University Clinical Center Tuzla
Verified postcode
Tuzla, Bosnia and Herzegovina
Astra Clinic
Verified postcode
Tallinn, Estonia
University Hospital Muenster, Institute Translational Neurology dept. Neurology
Verified postcode
Münster, Germany

Common questions

What is 'relapsing MS'?

Relapsing MS means you have periods where your MS symptoms get worse or new symptoms appear (called relapses), followed by times when symptoms improve or go away (remissions).

What is a 'placebo'?

A placebo is a dummy tablet that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the new medicine's effects.

How long will the treatment period last?

The main part of the treatment where you receive either the study drug or placebo will last for about 15 months. Some people may then continue on the active drug for up to 8 years.

Will I know if I'm getting the real drug or a placebo?

No, during the main 15-month treatment period, neither you nor your study doctor will know whether you are receiving IMU-838 or the placebo. This helps ensure the study results are fair.

What kind of tests will I have?

You can expect various checks, scans, and blood tests during your appointments to monitor your MS and overall health throughout the study.