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.
Plain-language title generated from the registry record
Registry title: A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years
Key facts
- Where
- Boston, Dallas, El Paso, Farmington Hills, Oklahoma City, Ozark, Plano, and St Louis, United StatesSee the 8 sites
- Phase
- Phase 2
Could this be for you?
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?
Source: NCT06735248, who can take part
Where in United States
- Boston Clinical Trials Inc - Internal MedicineBoston, United StatesNo longer taking part
- University of Texas Southwestern Medical CenterDallas, United StatesTaking people
- ANESC ResearchEl Paso, United StatesTaking people
- QUEST Research InstituteFarmington Hills, United StatesTaking people
- Oklahoma Medical Research Foundation (OMRF) MS Center of ExcellenceOklahoma City, United StatesTaking people
- Sharlin Health & NeurologyOzark, United StatesNo longer taking part
- Saturn Research SolutionsPlano, United StatesTaking people
- Washington University School of Medicine Neurology Clinical UnitSt Louis, United StatesTaking people
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?
Trial details
- Who runs it
- ModernaTX, Inc.
- Trial code
- NCT06735248EU 2024-517949-13-00
- Record updated
- 15 June 2026
- Original description
The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis.Read full original descriptionShow less
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
The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis.
Inclusion: 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: 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.