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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.
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

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of the Sunshine Coast Clinical Trials
Coordinator of this site? Confirm its status
BirtinyaAustraliaRecruiting
North Bristol NHS Trust - Southmead Hospital
Coordinator of this site? Confirm its status
BristolUnited KingdomRecruiting
Cardiff and Vale University Health Board - University Hospital Wales
Coordinator of this site? Confirm its status
CardiffUnited KingdomRecruiting
Anne Rowling Regenerative Neurology Clinic, University of Edinburgh
Coordinator of this site? Confirm its status
EdinburghUnited KingdomRecruiting
NHS Greater Glasgow & Clyde - Institute of Neurological Sciences
Coordinator of this site? Confirm its status
GlasgowUnited KingdomRecruiting
East Kent Hospitals University NHS Foundation Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Cambridge Clinical Research Centre
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Coordinator of this site? Confirm its status
Newcastle upon TyneUnited KingdomRecruiting
Sheffield Teaching Hospital NHS foundation Trust, Herries Road
Coordinator of this site? Confirm its status
SheffieldUnited KingdomRecruiting
Boston Clinical Trials Inc - Internal Medicine
Coordinator of this site? Confirm its status
BostonUnited StatesTerminated
University of Texas Southwestern Medical Center
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
ANESC Research
Coordinator of this site? Confirm its status
El PasoUnited StatesRecruiting
QUEST Research Institute
Coordinator of this site? Confirm its status
Farmington HillsUnited StatesRecruiting
Oklahoma Medical Research Foundation (OMRF) MS Center of Excellence
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesRecruiting
Sharlin Health & Neurology
Coordinator of this site? Confirm its status
OzarkUnited StatesTerminated
Saturn Research Solutions
Coordinator of this site? Confirm its status
PlanoUnited StatesRecruiting
Washington University School of Medicine Neurology Clinical Unit
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.