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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
Where Is This Study? (8 UK sites)
North Bristol NHS Trust - Southmead Hospital
Bristol BS10 5NB, United Kingdom
Cardiff and Vale University Health Board - University Hospital Wales
Cardiff CF14 4XW, United Kingdom
Anne Rowling Regenerative Neurology Clinic, University of Edinburgh
Edinburgh EH16 4SB, United Kingdom
NHS Greater Glasgow & Clyde - Institute of Neurological Sciences
Glasgow G51 4TF, United Kingdom
Cambridge Clinical Research Centre
London CB2 0SL, United Kingdom
East Kent Hospitals University NHS Foundation Trust
London CT1 3NG, United Kingdom
Caroline Cowley, Research & Innovation/Clinical Trials Unit Manager
ekhuft.researchandinnovation@nhs.net01227 783169The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne NE14LP, United Kingdom
Sheffield Teaching Hospital NHS foundation Trust, Herries Road
Sheffield S10 2JF, United Kingdom
How to Get in Touch
Moderna WeCare Team
Sponsor contactCONTACT
