Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase2

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

Sponsor: ModernaTX, Inc.

NCT ID: NCT06735248

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
mRNA-1195 (biological), Placebo (biological)
How long the study runs
Study runs about 45 months (dates as stated)
About the drug or intervention
mRNA-1195 — biological: IM injection · Placebo — biological: IM injection
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by ModernaTX, Inc., is testing an experimental treatment called mRNA-1195 against a placebo (a dummy treatment with no active medicine) to see if it can help prevent relapses in people with multiple sclerosis, a condition where the immune system affects the nerves. It is for people aged 18 to 55. The study focuses on people early in their multiple sclerosis course.

Who can take part

  • You are medically stable, based on a doctor's assessment including your medical history, a physical examination, laboratory tests and a review of any previous heart monitoring.
  • You have evidence of past infection with the Epstein-Barr virus (a common virus), shown by a blood test at screening.
  • You have been diagnosed with relapsing multiple sclerosis — including after a single attack (clinically isolated syndrome) or a diagnosis called radiologically isolated syndrome — within the last 24 months, and a doctor believes you have been neurologically stable for at least 30 days before the first study visit.
  • If you could become pregnant, you can take part if you are not pregnant, not breast or chest feeding, and you use a highly effective form of contraception.

Who may not be able to

  • You are acutely ill or have a fever of 38.0°C (100.4°F) or higher within 72 hours before or at screening or Day 1.
  • You have a condition or diagnosis that a doctor judges to be unstable or that could affect your safety, the study assessments, your immune response or your ability to follow the study procedures.
  • You have had, or plan to have, any non-study vaccine (including any COVID-19 vaccine) within 28 days before or after any study injection, or a flu vaccine within 14 days before or after any study injection.
  • You have any medical, mental health or work-related condition, including a history of drug or alcohol misuse, that a doctor thinks could put you at extra risk or affect the study results.
  • You have taken medicines that suppress the immune system (by mouth or injection into the bloodstream) in the 30 days before screening — for steroid medicines, this means 10 mg or more per day of prednisone or an equivalent.
  • You have any recorded history of myocarditis, pericarditis or myopericarditis (types of heart inflammation).
  • You have donated 450 mL or more of blood within 28 days before screening, or plan to donate blood within 28 days after a study injection.
  • Other inclusion and exclusion criteria may apply.

What taking part involves

  • • Receiving study injections of either mRNA-1195 or a placebo (a dummy treatment). Not stated — ask the trial team for details of how many injections you would receive and what else the treatment involves.

Time commitment: Not stated — ask the trial team about the number of visits, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 55 Years
Who
All
Number of participants
180
Started
2025-04-16
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for multiple sclerosis
  • • Phase2 - 180 participants
  • • The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis

Who can take part?

  • • Ages 18 Years to 55 Years
  • • Diagnosed with multiple sclerosis

Where?

  • • Bristol - North Bristol NHS Trust - Southmead Hospital
  • • Cardiff - Cardiff and Vale University Health Board - University Hospital Wales
  • • Edinburgh - Anne Rowling Regenerative Neurology Clinic, University of Edinburgh
  • • Glasgow - NHS Greater Glasgow & Clyde - Institute of Neurological Sciences
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis.

Multiple Sclerosis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 55 Years
  • Who can join: All genders

What the study is looking for

  • ✓Participants who are Epstein-Barr virus (EBV)-seropositive at screening.
  • ✓A participant who could become pregnant is eligible to participate if they are not pregnant or breast/chest feeding...

Who cannot take part

  • ✗Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) \[100.4 Fahrenheit °F\]) within 72 hours prior to or...
  • ✗Received systemic immunosuppressants within the 30 day period prior to screening (for corticosteroids, ≥10...
  • ✗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...
  • ✗Note: Other inclusion and exclusion criteria may apply.
See the full criteria
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.

Where Is This Study? (8 UK sites)

North Bristol NHS Trust - Southmead Hospital

Bristol BS10 5NB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Helen Lewis-White

Research@nbt.nhs.uk0117 41 49330

Cardiff and Vale University Health Board - University Hospital Wales

Cardiff CF14 4XW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Martin

research.development@wales.nhs.uk029 2074 6986

Anne Rowling Regenerative Neurology Clinic, University of Edinburgh

Edinburgh EH16 4SB, United Kingdom

Recruiting

NHS Greater Glasgow & Clyde - Institute of Neurological Sciences

Glasgow G51 4TF, United Kingdom

Recruiting
Hospital R&D contact (matched)

Radek Penar

radoslaw.penar@nhs.scotn/a

Cambridge Clinical Research Centre

London CB2 0SL, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

East Kent Hospitals University NHS Foundation Trust

London CT1 3NG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Caroline Cowley, Research & Innovation/Clinical Trials Unit Manager

ekhuft.researchandinnovation@nhs.net01227 783169

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne NE14LP, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development

nuth.genericqueries@nhs.net0191 282 4926

Sheffield Teaching Hospital NHS foundation Trust, Herries Road

Sheffield S10 2JF, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

How to Get in Touch

Moderna WeCare Team

Sponsor contact

CONTACT

1-866-663-3762 WeCareClinicalTrials@modernatx.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-06