Actively Recruiting

Phase 2
Age: 18Years - 55Years
All Genders
NCT06735248

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

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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