NCT06735248RecruitingPhase 2
A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years
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
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 11 Dec 2024
- Start date
- 16 Apr 2025
- Primary completion date
- 8 Jan 2029
- Lead sponsor
- ModernaTX, Inc.
- Diseases
- Multiple sclerosis
- NCT number
- NCT06735248
- EU CT number
- 2024-517949-13-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 180
- From 16 Apr 2025 to the primary completion date, 8 Jan 2029
- 17 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of the Sunshine Coast Clinical Trials Coordinator of this site? Confirm its status | Birtinya | Australia | Recruiting |
| North Bristol NHS Trust - Southmead Hospital Coordinator of this site? Confirm its status | Bristol | United Kingdom | Recruiting |
| Cardiff and Vale University Health Board - University Hospital Wales Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Recruiting |
| Anne Rowling Regenerative Neurology Clinic, University of Edinburgh Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Recruiting |
| NHS Greater Glasgow & Clyde - Institute of Neurological Sciences Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
| East Kent Hospitals University NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Cambridge Clinical Research Centre Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The Newcastle Upon Tyne Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Recruiting |
| Sheffield Teaching Hospital NHS foundation Trust, Herries Road Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| Boston Clinical Trials Inc - Internal Medicine Coordinator of this site? Confirm its status | Boston | United States | Terminated |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| ANESC Research Coordinator of this site? Confirm its status | El Paso | United States | Recruiting |
| QUEST Research Institute Coordinator of this site? Confirm its status | Farmington Hills | United States | Recruiting |
| Oklahoma Medical Research Foundation (OMRF) MS Center of Excellence Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Sharlin Health & Neurology Coordinator of this site? Confirm its status | Ozark | United States | Terminated |
| Saturn Research Solutions Coordinator of this site? Confirm its status | Plano | United States | Recruiting |
| Washington University School of Medicine Neurology Clinical Unit Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.