Tests safety of mRNA-1195 injection against placebo in adults with multiple sclerosis
Tests the safety of mRNA-1195 injection against placebo in adults with multiple sclerosis.
Key facts
- Who runs it
- ModernaTX, Inc.
- Where
- Bristol, Cardiff, Edinburgh, Glasgow, London, Newcastle upon Tyne, and Sheffield, United KingdomSee the 8 sitesAlso in 2 other countries, 9 sites
- Trial code
- Registry title
- A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 180 people, planned
- Started
- 16 Apr 2025
- Expected to end
- 8 Jan 2029
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- mRNA-1195
- Placebo
- Record updated
- 15 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 55 with early relapsing multiple sclerosis who have been exposed to Epstein-Barr virus. It tests the safety of mRNA-1195 compared with placebo.
- Age
- 18 to 55 years
- Sex
- All sexes can join.
- Disease stage
- Relapsing multiple sclerosis, including a single clinical attack (clinically isolated syndrome) or radiologically isolated syndrome, diagnosed within 24 months before screening. Neurologically stable for at least 30 days before Day 1.
- Earlier treatment
- Cannot have taken systemic immunosuppressants in the 30 days before screening (for corticosteroids, 10 mg/day of prednisone or more). Cannot have had a non-study vaccine within 28 days before or after a study injection (14 days for the influenza vaccine).
- Biomarker or test result
- Must be positive for Epstein-Barr virus (EBV) antibodies at screening.
Main reasons for not taking part
- Acutely ill or fever of 38.0 degrees Celsius or higher within 72 hours before screening or Day 1
- Any past myocarditis, pericarditis or myopericarditis
- Pregnant or breast/chest feeding
- A medical, psychiatric or other condition that could add risk or affect the study results
- Blood donation of 450 mL or more within 28 days before screening
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) [100.4 Fahrenheit °F]) within 72 hours prior to or at screening or Day 1
- 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
- Received systemic immunosuppressants within the 30 day period prior to screening (for corticosteroids, ≥10 milligrams (mg)/day of prednisone or equivalent)
- 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
- 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
- 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
- Participants with any documented history of myocarditis, pericarditis, or myopericarditis
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Where in United Kingdom
Also in 2 other countries, 9 sites
- North Bristol NHS Trust - Southmead HospitalBristol, United KingdomContact: Moderna WeCare TeamTaking people
- Cardiff and Vale University Health Board - University Hospital WalesCardiff, United KingdomContact: Moderna WeCare TeamTaking people
- Anne Rowling Regenerative Neurology Clinic, University of EdinburghEdinburgh, United KingdomContact: Moderna WeCare TeamTaking people
- NHS Greater Glasgow & Clyde - Institute of Neurological SciencesGlasgow, United KingdomContact: Moderna WeCare TeamTaking people
- Cambridge Clinical Research CentreLondon, United KingdomContact: Moderna WeCare TeamTaking people
- East Kent Hospitals University NHS Foundation TrustLondon, United KingdomContact: Moderna WeCare TeamTaking people
- The Newcastle Upon Tyne Hospitals NHS Foundation TrustNewcastle upon Tyne, United KingdomContact: Moderna WeCare TeamTaking people
- Sheffield Teaching Hospital NHS foundation Trust, Herries RoadSheffield, United KingdomContact: Moderna WeCare TeamTaking people
About the trial
What the trial wants to find out
The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis.
The 3 groups in the trial
- mRNA-1195 Dose Level 1 (Low Dose)Treatment being tested
Participants will receive 3 intramuscular (IM) injections at dose level 1 (low dose) on a 0-, 2-, and 6-month schedule.
Treatment: mRNA-1195
- mRNA-1195 Dose Level 2 (High Dose)Treatment being tested
Participants will receive 3 IM injections at dose level 2 (high dose) on a 0-, 2-, and 6-month schedule.
Treatment: mRNA-1195
- PlaceboPlacebo, for comparison
Participants will receive 3 placebo IM injections on a 0-, 2-, and 6-month schedule.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of mRNA-1195 Intramuscular Injection in Participants 18 to ≤55 Years of Age With Multiple Sclerosis
- Plain-language title
- Tests safety of mRNA-1195 injection against placebo in adults with multiple sclerosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06735248, who can take part
- Record updated
- 15 June 2026