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Investigating mRNA-1195 for preventing multiple sclerosis relapses

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

Phase 2 Interventional ModernaTX, Inc. · NCT06735248

This study is testing if a new treatment called mRNA-1195 can help prevent relapses in people aged 18 to 55 who have multiple sclerosis.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years to 55 Years
SexAll
SponsorModernaTX, Inc. Industry-sponsored
Drugs / interventionsprednisone
Locations17 sites (Boston, Massachusetts and 16 other locations)
Trial IDNCT06735248 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 18 to 55 with a recent diagnosis of multiple sclerosis or related conditions who are neurologically stable.

Not a fit: Patients who are acutely ill or have a history of conditions that may interfere with the study outcomes may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency of relapses in patients with multiple sclerosis.

How similar studies have performed: While this approach using mRNA technology is relatively novel in the context of multiple sclerosis, similar studies have shown promise in other conditions.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Boston, Massachusetts and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple SclerosismRNA-1195MS
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.