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A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT06735248•ModernaTX, Inc.

View on ClinicalTrials.gov

Summary

The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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.

Locations (17)

Boston Clinical Trials Inc - Internal Medicine

Boston, Massachusetts, United States

Quest Research Institute

Farmington Hills, Michigan, United States

Sharlin Health & Neurology

Ozark, Missouri, United States

Washington University School of Medicine Neurology Clinical Unit

St Louis, Missouri, United States

Oklahoma Medical Research Foundation (OMRF) MS Center of Excellence

Oklahoma City, Oklahoma, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

ANESC Research

El Paso, Texas, United States

Saturn Research Solutions

Plano, Texas, United States

University of the Sunshine Coast Clinical Trials

Birtinya, Queensland, Australia

North Bristol NHS Trust - Southmead Hospital

Bristol, United Kingdom

Key Dates

Start Date

April 16, 2025

Primary Completion Date

January 8, 2029

Completion Date

January 8, 2029

Last Updated

December 22, 2025

Enrollment

180

ESTIMATED participants

Conditions

Multiple Sclerosis

Interventions

mRNA-1195

BIOLOGICAL

Placebo

BIOLOGICAL

Contacts

Moderna WeCare Team

CONTACT

1-866-663-3762 WeCareClinicalTrials@modernatx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years

Inclusion Criteria

Exclusion Criteria

Intermittent Hypoxia in Persons With Multiple Sclerosis

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