mRNA-1195 for Multiple Sclerosis Relapse Prevention
This study is testing a new treatment called mRNA-1195 to see if it can help prevent relapses in people with multiple sclerosis (MS). Researchers want to understand how safe mRNA-1195 is and how people react to it, compared to a placebo (an inactive substance). You might be able to join if you are between 18 and 55 years old, have MS, and have tested positive for the Epstein-Barr virus (EBV). The study will look at any side effects you experience, both expected and unexpected, to determine the treatment's safety. The current status of this study is unclear, but it plans to enroll about 180 participants.
- Study design
- This is an interventional study comparing mRNA-1195 to a placebo, with approximately 180 participants planned.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for adverse reactions up to 176 days after the last injection, and for other adverse events up to 347 days (about 6 months) after the last injection.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06735248
A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years
Recruiting
PHASE2Ages 18–55InterventionalTreatmentModernaTX, Inc.
~180 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:mRNA-1195Placebo
At a glance
Recruiting sites
15 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Measured over Up to Day 176 (7 days after each study injection)
+3 more outcomes measured
Conditions
Where it's being run
17 sites across 7 statesUnited Kingdom8
Texas3
Missouri2
Massachusetts1
Michigan1
Oklahoma1
Queensland1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
What this trial measures
- Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)Up to Day 176 (7 days after each study injection)
- Number of Participants with Unsolicited Adverse Events (AEs)Up to Day 197 (28 days after each study injection)
- Number of Participants with Medically Attended Adverse Events (MAAEs)Up to Day 347 (up to 6 months after last study injection)
- Number of Participants with Adverse Events of Special Interest (AESI), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention and/or Study ParticipationUp to Day 887 (end of study)