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RecruitingPhase 2

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

ModernaTX, Inc. · NCT06735248

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–55 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
180
US sites recruiting
6
Study start
April 16, 2025
Record last updated
June 15, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: mRNA-1195; Placebo

Conditions: Multiple Sclerosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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 (℃) [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.

Note: Other inclusion and exclusion criteria may apply.

Recruiting US locations

  • Quest Research Institute

    Farmington Hills, MI 48334

  • Washington University School of Medicine Neurology Clinical Unit

    St Louis, MO 63110

  • Oklahoma Medical Research Foundation (OMRF) MS Center of Excellence

    Oklahoma City, OK 73104

  • University of Texas Southwestern Medical Center

    Dallas, TX 75390-8806

  • ANESC Research

    El Paso, TX 79912

    Site contact: Frank Chairz · 915-974-2200 · fchairez@anesc.net

  • Saturn Research Solutions

    Plano, TX 75024

Study contacts (from the official record)

  • Moderna WeCare Team · 1-866-663-3762 · WeCareClinicalTrials@modernatx.com
All neurology studies in Michigan →
A Study to Investigate Multiple Sclerosis Relapse Prevention With… (NCT06735248) | Bored Studies