RightFit
RecruitingPhase 2

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

A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of mRNA-1195 Intramuscular Injection in Participants 18 to ≤55 Years of Age With Multiple Sclerosis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares mRNA-1195 with a placebo to study multiple sclerosis (MS) relapse prevention. Its main goal is to check safety and reactions after injections. It is for adults ages 18 to 55 who are early in their MS course or have early signs of MS.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18 to 55 years old.
  • Are medically stable, based on the study doctor's exam, health history, and test results.
  • Have a positive blood test for Epstein-Barr virus (EBV).
  • Were diagnosed within 24 months before screening with MS that has flare-ups, one attack of MS-like symptoms, or scan findings suggesting MS without symptoms.
  • Have had stable nerve and brain symptoms for at least 30 days before the first study visit, as judged by the study doctor.
  • If you could become pregnant, are not pregnant or breast/chest feeding and use highly effective birth control.

Who can't join

  • Are sick with a short-term illness or have a fever of 100.4°F (38°C) or higher within 72 hours before, or at, screening or Day 1.
  • Have an unstable health condition, or one that could affect safety, immune response, study results, or your ability to follow study steps.
  • Received or plan to receive another vaccine within 28 days before or after a study injection. For flu vaccines, the limit is 14 days.
  • Have a medical, mental health, or work-related condition, including a history of drug or alcohol abuse, that the study doctor believes could add risk or affect study results.
  • Took medicines that weaken the immune system throughout the body within 30 days before screening. For steroids, this means prednisone at 10 mg a day or more, or an equal dose of another steroid.
  • Have a documented history of swelling of the heart muscle, the sac around the heart, or both.
  • Donated at least 450 mL of blood products within 28 days before screening, or plan to donate blood products within 28 days after a study injection.
  • Other study rules may also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (8)

MA

MI

MO

OK

TX