RecruitingPhase 2NCT06735248

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

Sponsor

ModernaTX, Inc.

Enrollment

180 participants

Start Date

Apr 16, 2025

Study Type

INTERVENTIONAL

Conditions

Multiple Sclerosis

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an experimental mRNA vaccine called mRNA-1195 — similar in technology to COVID-19 vaccines — can prevent relapses (flare-ups) in people with relapsing multiple sclerosis (MS). **You may be eligible if...** - You are between 18 and 55 years old - You have a diagnosis of relapsing MS, including early-stage MS (clinically isolated syndrome or radiologically isolated syndrome), diagnosed within the last 24 months - You have tested positive for Epstein-Barr virus (EBV) — a common virus that most adults have - You are medically stable **You may NOT be eligible if...** - You have a more advanced or progressive form of MS - You have not been exposed to EBV - You have another medical condition that makes participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALmRNA-1195

IM injection

BIOLOGICALPlacebo

IM 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

Cardiff and Vale University Health Board - University Hospital Wales

Cardiff, United Kingdom

Anne Rowling Regenerative Neurology Clinic, University of Edinburgh

Edinburgh, United Kingdom

NHS Greater Glasgow & Clyde - Institute of Neurological Sciences

Glasgow, United Kingdom

Cambridge Clinical Research Centre

London, United Kingdom

East Kent Hospitals University NHS Foundation Trust

London, United Kingdom

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

Sheffield Teaching Hospital NHS foundation Trust, Herries Road

Sheffield, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06735248

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