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MRNA shot takes on MS: moderna launches brain lesion trial

NCT ID NCT06735248

Disease control Sponsor: ModernaTX, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tests an experimental mRNA therapy called mRNA-1195 in 180 adults aged 18 to 55 with relapsing multiple sclerosis. Participants receive either the mRNA shot or a placebo, and researchers monitor safety and measure new brain lesions on MRI scans over about 2.5 years. The goal is to see if the treatment is safe and may reduce disease activity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mRNA-1195 (a messenger RNA therapy given as a shot into the muscle)
What this could lead to
If successful, this could point toward a new treatment option that reduces brain lesions and slows disease activity in relapsing multiple sclerosis.
What could go wrong
This is an early Phase 2 trial with only 180 participants, so results may not apply to everyone. The main goal is safety, not yet proof of effectiveness. Side effects from the injection or immune reactions are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Medically stable as determined by Investigator's medical evaluation, which will include assessment of medical history, physical examination, laboratory testing, and review of any previously conducted cardiac monitoring. * Participants who are Epstein-Barr virus (EBV)-seropositive at screening. * Participants diagnosed with relapsing multiple sclerosis, including those with a single clinical attack (that is, clinically isolated syndrome \[CIS\]), as well as participants diagnosed with radiologically isolated syndrome, within 24 months of Screening Visit (that is, early in their multiple sclerosis course) and in the opinion of the Investigator have been neurologically stable for at least 30 days prior to Visit 1/Day 1. * A participant who could become pregnant is eligible to participate if they are not pregnant or breast/chest feeding and using a highly effective contraceptive method. Exclusion Criteria: * Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) \[100.4 Fahrenheit °F\]) within 72 hours prior to or at screening or Day 1. * History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures. * Received or plans to receive any non-study vaccine (including authorized or approved vaccines for the prevention of coronavirus disease 2019 \[COVID-19\] regardless of vaccine type) within 28 days before or after any study injection, or within 14 days before or after any study injection for the influenza vaccine. * Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results. * Received systemic immunosuppressants within the 30 day period prior to screening (for corticosteroids, ≥10 milligrams (mg)/day of prednisone or equivalent) * Participants with any documented history of myocarditis, pericarditis, or myopericarditis. * Has donated ≥450 milliliter (mL) of blood products within 28 days prior to screening or plans to donate blood products within 28 days post-study injection. Note: Other inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ANESC Research

    RECRUITING

    El Paso, Texas, 79912, United States

  • Anne Rowling Regenerative Neurology Clinic, University of Edinburgh

    RECRUITING

    Edinburgh, EH16 4SB, United Kingdom

  • Boston Clinical Trials Inc - Internal Medicine

    TERMINATED

    Boston, Massachusetts, 02131, United States

  • Cambridge Clinical Research Centre

    RECRUITING

    London, CB2 0SL, United Kingdom

  • Cardiff and Vale University Health Board - University Hospital Wales

    RECRUITING

    Cardiff, CF14 4XW, United Kingdom

  • East Kent Hospitals University NHS Foundation Trust

    RECRUITING

    London, CT1 3NG, United Kingdom

  • NHS Greater Glasgow & Clyde - Institute of Neurological Sciences

    RECRUITING

    Glasgow, G51 4TF, United Kingdom

  • North Bristol NHS Trust - Southmead Hospital

    RECRUITING

    Bristol, BS10 5NB, United Kingdom

  • Oklahoma Medical Research Foundation (OMRF) MS Center of Excellence

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Quest Research Institute

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • Saturn Research Solutions

    RECRUITING

    Plano, Texas, 75024, United States

  • Sharlin Health & Neurology

    TERMINATED

    Ozark, Missouri, 65721, United States

  • Sheffield Teaching Hospital NHS foundation Trust, Herries Road

    RECRUITING

    Sheffield, S10 2JF, United Kingdom

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    RECRUITING

    Newcastle upon Tyne, NE14LP, United Kingdom

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390-8806, United States

  • University of the Sunshine Coast Clinical Trials

    RECRUITING

    Birtinya, Queensland, 04575, Australia

  • Washington University School of Medicine Neurology Clinical Unit

    RECRUITING

    St Louis, Missouri, 63110, United States

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