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RecruitingPhase 2NCT06735248

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

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Trial Parameters

ConditionMultiple Sclerosis
SponsorModernaTX, Inc.
Study TypeINTERVENTIONAL
PhasePhase 2
Enrollment180
SexALL
Min Age18 Years
Max Age55 Years
Start Date2025-04-16
Completion2029-01-08
Interventions
mRNA-1195Placebo

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Brief Summary

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

Eligibility Criteria

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 (℃

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