Actively Recruiting
A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years
Led by ModernaTX, Inc. · Updated on 2025-12-22
180
Participants Needed
17
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis.
CONDITIONS
Official Title
A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Medically stable as determined by the Investigator's medical evaluation including history, physical exam, lab testing, and cardiac monitoring review
- Epstein-Barr virus (EBV) seropositive at screening
- Diagnosed with relapsing multiple sclerosis or clinically isolated syndrome within 24 months of screening and neurologically stable for at least 30 days before first dose
- If able to become pregnant, not pregnant or breastfeeding and using a highly effective contraceptive method
You will not qualify if you...
- Acutely ill or feverish (temperature ≥38.0°C [100.4°F]) within 72 hours before screening or first dose
- Any unstable medical condition that may affect safety, immune response assessment, or study adherence
- Received or plans to receive any non-study vaccine within 28 days before or after study injection (14 days for flu vaccine)
- Any medical, psychiatric, or occupational condition, including history of drug or alcohol abuse, that may increase risk or interfere with study results
- Received systemic immunosuppressants (≥10 mg/day prednisone or equivalent) within 30 days before screening
- History of myocarditis, pericarditis, or myopericarditis
- Donated ≥450 mL blood within 28 days before screening or plans to donate within 28 days post-study injection
- Other criteria may also apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Boston Clinical Trials Inc - Internal Medicine
Boston, Massachusetts, United States, 02131
Actively Recruiting
2
Quest Research Institute
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
3
Sharlin Health & Neurology
Ozark, Missouri, United States, 65721
Actively Recruiting
4
Washington University School of Medicine Neurology Clinical Unit
St Louis, Missouri, United States, 63110
Actively Recruiting
5
Oklahoma Medical Research Foundation (OMRF) MS Center of Excellence
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
6
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-8806
Actively Recruiting
7
ANESC Research
El Paso, Texas, United States, 79912
Actively Recruiting
8
Saturn Research Solutions
Plano, Texas, United States, 75024
Actively Recruiting
9
University of the Sunshine Coast Clinical Trials
Birtinya, Queensland, Australia, 04575
Actively Recruiting
10
North Bristol NHS Trust - Southmead Hospital
Bristol, United Kingdom, BS10 5NB
Actively Recruiting
11
Cardiff and Vale University Health Board - University Hospital Wales
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
12
Anne Rowling Regenerative Neurology Clinic, University of Edinburgh
Edinburgh, United Kingdom, EH16 4SB
Actively Recruiting
13
NHS Greater Glasgow & Clyde - Institute of Neurological Sciences
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
14
Cambridge Clinical Research Centre
London, United Kingdom, CB2 0SL
Actively Recruiting
15
East Kent Hospitals University NHS Foundation Trust
London, United Kingdom, CT1 3NG
Actively Recruiting
16
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom, NE14LP
Actively Recruiting
17
Sheffield Teaching Hospital NHS foundation Trust, Herries Road
Sheffield, United Kingdom, S10 2JF
Actively Recruiting
Research Team
M
Moderna WeCare Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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