A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Multiple Sclerosis
In brief
The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis.
Key facts
- Study ID
- NCT06735248
- Run by
- ModernaTX, Inc.
- People needed
- 180
- Starts
- 2025-04-16
- Expected to finish
- 2029-01-08
- Last updated by the study team
- 2026-06-15
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Sheffield Teaching Hospital NHS foundation Trust, Herries Road — Sheffield, United Kingdom (enrolling)
- Quest Research Institute — Farmington Hills, Michigan, United States (enrolling)
- East Kent Hospitals University NHS Foundation Trust — London, United Kingdom (enrolling)
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne, United Kingdom (enrolling)
- Washington University School of Medicine Neurology Clinical Unit — St Louis, Missouri, United States (enrolling)
- Oklahoma Medical Research Foundation (OMRF) MS Center of Excellence — Oklahoma City, Oklahoma, United States (enrolling)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
- ANESC Research — El Paso, Texas, United States (enrolling)
- Saturn Research Solutions — Plano, Texas, United States (enrolling)
- University of the Sunshine Coast Clinical Trials — Birtinya, Queensland, Australia (enrolling)
- North Bristol NHS Trust - Southmead Hospital — Bristol, United Kingdom (enrolling)
- Cardiff and Vale University Health Board - University Hospital Wales — Cardiff, United Kingdom (enrolling)
- Anne Rowling Regenerative Neurology Clinic, University of Edinburgh — Edinburgh, United Kingdom (enrolling)
- NHS Greater Glasgow & Clyde - Institute of Neurological Sciences — Glasgow, United Kingdom (enrolling)
- Cambridge Clinical Research Centre — London, United Kingdom (enrolling)
- Sharlin Health & Neurology — Ozark, Missouri, United States
- Boston Clinical Trials Inc - Internal Medicine — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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