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

Launched by MODERNATX, INC. · Dec 11, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called mRNA-1195 to see if it can help prevent relapses in people with early multiple sclerosis (MS). The study aims to understand how safe the treatment is and how it affects the body. It is designed for adults between the ages of 18 and 55 who are in stable health and have tested positive for the Epstein-Barr virus, which is a common virus that many people carry.

If you or a family member is considering participating in this trial, you'll need to meet certain health criteria, such as being free from any serious illness or infection in the days leading up to the study. You should not have any conditions that might complicate the study results or your health during the trial. Participants will receive either the mRNA-1195 treatment or a placebo (a substance with no active treatment) and will be monitored closely for any side effects. The study is not currently recruiting participants, but it’s a chance to contribute to research that could benefit others with MS in the future.

Gender

ALL

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 (℃) \[100.4 Fahrenheit °F\]) 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.