A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years
NCT ID: NCT06735248
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
180 participants
INTERVENTIONAL
2025-04-16
2029-01-08
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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mRNA-1195 Dose Level 1 (Low Dose)
Participants will receive 3 intramuscular (IM) injections at dose level 1 (low dose) on a 0-, 2-, and 6-month schedule.
mRNA-1195
IM injection
mRNA-1195 Dose Level 2 (High Dose)
Participants will receive 3 IM injections at dose level 2 (high dose) on a 0-, 2-, and 6-month schedule.
mRNA-1195
IM injection
Placebo
Participants will receive 3 placebo IM injections on a 0-, 2-, and 6-month schedule.
Placebo
IM injection
Interventions
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mRNA-1195
IM injection
Placebo
IM injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
No
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Frank Chairz
Role: primary
Other Identifiers
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2024-517949-13-00
Identifier Type: OTHER
Identifier Source: secondary_id
mRNA-1195-P201
Identifier Type: -
Identifier Source: org_study_id