Investigating mRNA-1195 for preventing multiple sclerosis relapses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to evaluate the safety and reactogenicity of mRNA-1195 in individuals aged 18 to 55 who have been diagnosed with multiple sclerosis or related conditions. Participants will be randomly assigned to receive either the mRNA-1195 treatment or a placebo. The study will assess the effectiveness of mRNA-1195 in preventing relapses of multiple sclerosis over a specified period. The trial is designed to gather data on how well the treatment works and its safety profile in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Quest Research Institute
  Farmington Hills, Michigan, United States Recruiting
• Washington University School of Medicine Neurology Clinical Unit
  St Louis, Missouri, United States Recruiting
• Oklahoma Medical Research Foundation (OMRF) MS Center of Excellence
  Oklahoma City, Oklahoma, United States Recruiting
• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting
• ANESC Research
  El Paso, Texas, United States Recruiting
• Saturn Research Solutions
  Plano, Texas, United States Recruiting

Study contacts

• Study coordinator: Moderna WeCare Team
• Email: WeCareClinicalTrials@modernatx.com
• Phone: 1-866-663-3762

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.