RecruitingPHASE2INTERVENTIONAL

A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years

This research study is testing a new medication, mRNA-1195, for people with Multiple Sclerosis (MS). The main goal is to understand how safe mRNA-1195 is and what side effects it might have, compared to a 'dummy' treatment called a placebo. We are particularly interested in seeing if it can help prevent MS relapses, which are sudden worsening of symptoms. This study is for people aged 18 to 55 who have been recently diagnosed with MS. By taking part, you could help scientists learn more about new ways to manage MS and potentially improve treatments for many people in the future.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

ModernaTX, Inc.

Enrolment target

180

Start

16 Apr 2025

Estimated completion

08 Jan 2029

Multiple Sclerosis

What is this study about?

This study is looking into a new medication called mRNA-1195. It's designed to see if it can help people with Multiple Sclerosis (MS) by potentially preventing relapses, which are times when MS symptoms suddenly get worse. The study is comparing this new medicine with a 'placebo', which looks like the real medicine but contains no active drug. This helps researchers understand if any changes are due to the medicine itself or other factors.

The main aim is to find out how safe mRNA-1195 is and how people's bodies react to it. This kind of early research is really important because it helps us understand if a new treatment has the potential to be helpful and safe for people with MS in the long run. By joining, you'd be helping doctors learn more about MS and potentially find new ways to improve the lives of those affected by it.

This study is a 'Phase 2' trial. This means it's one of the earlier steps in testing a new medicine, focusing on its safety and finding the right dose, rather than a very large study designed to prove it works better than existing treatments. The information gathered here will help decide if mRNA-1195 should be tested in even bigger studies.

Key takeaways

This study tests a new medicine (mRNA-1195) for MS relapse prevention.
It aims to check the medicine's safety and how the body reacts to it.
It's for people aged 18-55 with a recent MS diagnosis.
Participants will receive either the new medicine or a dummy treatment.
Regular health check-ups and follow-up appointments are part of the study.
Your participation helps advance MS research.

Who may be eligible?

To join this study, you need to be generally healthy, as decided by the study doctor, and have a clear medical history, including some blood tests. You must also have had the Epstein-Barr virus (EBV) in the past, which is a common virus. Importantly, you need to have been diagnosed with a type of MS called relapsing MS, or have had a 'clinically isolated syndrome' (CIS) or 'radiologically isolated syndrome' within the last two years. This means the study is for people in the earlier stages of their MS. Also, your MS symptoms must have been stable for at least a month before starting the study.

There are also some reasons why you might not be able to join. For instance, if you have a fever or are acutely unwell close to the start of the study, or if you have any other serious condition that the study doctor thinks might make it unsafe for you to take part or affect the study results. You also can't receive certain other vaccines (like flu or COVID-19 vaccines) within a specific time frame before or after getting the study medicine. If you've recently taken strong medicines to suppress your immune system, you might not be eligible either. Finally, if you could become pregnant, you must not be pregnant or breastfeeding and need to use highly effective birth control.

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?
Have you been diagnosed with relapsing MS, CIS, or RIS within the last two years?
Has your MS been stable for at least one month?
Are you generally healthy, as deemed by a doctor?
For women who could become pregnant, are you using effective birth control and not pregnant or breastfeeding?
Have you avoided other vaccines recently (excluding flu, unless within 14 days)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the new medicine, mRNA-1195, or a dummy treatment (placebo). Neither you nor your study doctor will know which one you receive. You'll have several visits to the study clinic for check-ups, which will include physical exams, blood tests, and probably questionnaires about how you're feeling and any symptoms you have. The study will look at how your body reacts to the medicine and if you have any side effects. You'll need to agree to follow the study schedule and attend all your appointments. The total length of your involvement in the study will be explained to you by the study team.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as contributing to medical knowledge that might help others with MS in the future, and you'll receive careful medical monitoring throughout the study. However, there are also potential risks, including side effects from the study medicine or placebo, which could be mild (like soreness at the injection site) or more serious. The study medicine is still in trials, so its full effects aren't yet known. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (17)

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

Boston Clinical Trials Inc - Internal Medicine
Verified postcode
Boston, United States· Recruiting
Quest Research Institute
Verified postcode
Farmington Hills, United States· Recruiting
Sharlin Health & Neurology
Verified postcode
Ozark, United States· Recruiting
Washington University School of Medicine Neurology Clinical Unit
Verified postcode
St Louis, United States· Recruiting
Oklahoma Medical Research Foundation (OMRF) MS Center of Excellence
Verified postcode
Oklahoma City, United States· Recruiting
University of Texas Southwestern Medical Center
Verified postcode
Dallas, United States· Recruiting
ANESC Research
Verified postcode
El Paso, United States· Recruiting
Saturn Research Solutions
Verified postcode
Plano, United States· Recruiting
University of the Sunshine Coast Clinical Trials
Verified postcode
Birtinya, Australia· Recruiting
North Bristol NHS Trust - Southmead Hospital
Verified postcode
Bristol, United Kingdom· Recruiting
Cardiff and Vale University Health Board - University Hospital Wales
Verified postcode
Cardiff, United Kingdom· Recruiting
Anne Rowling Regenerative Neurology Clinic, University of Edinburgh
Verified postcode
Edinburgh, United Kingdom· Recruiting

Common questions

What is Multiple Sclerosis (MS)?

MS is a condition that affects your brain and spinal cord, causing problems with things like movement, balance, and vision. It's often known for periods of 'relapses' where symptoms get worse, followed by periods of recovery.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but doesn't contain any active drug. It helps researchers see if the real medicine is actually causing any changes, rather than other factors.

What does 'relapse prevention' mean?

Relapse prevention means trying to stop or reduce the number of times your MS symptoms suddenly get worse (a relapse).

How long will I be in the study?

The exact length of time for your participation will be explained by the study team, but these types of studies typically involve several months to a year or more of follow-up.

Can I still take my regular MS medication?

This will depend on your current medication and the study rules. The study team will review all your medicines to see if you are eligible and if any adjustments are needed.

How to find out more

Moderna WeCare Team

wecareclinicaltrials@modernatx.com 1-866-663-3762 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.