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NCT06735248 | NOT YET RECRUITING | Early Multiple Sclerosis

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

ModernaTX, Inc.

Brief Summary:

The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195.

Condition or disease

Early Multiple Sclerosis

Multiple Sclerosis

Intervention/treatment

mRNA-1195

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 180 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : 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 Early Multiple Sclerosis
Actual Study Start Date : 2025-04-28
Estimated Primary Completion Date : 2029-01-08
Estimated Study Completion Date : 2029-01-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Medically stable as determined by Investigator's medical evaluation, which will include assessment of medical history, physical examination, laboratory testing, and cardiac monitoring.
  • * Participants who are Epstein-Barr virus (EBV)-seropositive at screening.
  • * Participants who could become pregnant.
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 the Day 1 study injection, or within 14 days before or after Day 1 study intervention 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 for \>14 consecutive days within the 30 day period prior to screening (for corticosteroids, ≥10 milligrams (mg)/day of prednisone or equivalent)
  • * 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.
A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years

Location Details

NCT06735248

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How to Participate

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