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Clinical Trials in the USA / NCT06735248
Recruiting Phase 2

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

NCT06735248 · tracked via the Priya Life Science USA tracker
Sponsor
ModernaTX, Inc.
Phase
Phase 2
Started
2025-04-16
Last updated
2026-06-15

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

mRNA-1195Placebo

mRNA-1195: IM injection

Placebo: IM injection

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (17)

FacilityCityRegionStatus
Boston Clinical Trials Inc - Internal Medicine Boston Massachusetts Terminated
Quest Research Institute Farmington Hills Michigan Recruiting
Sharlin Health & Neurology Ozark Missouri Terminated
Washington University School of Medicine Neurology Clinical Unit St Louis Missouri Recruiting
Oklahoma Medical Research Foundation (OMRF) MS Center of Excellence Oklahoma City Oklahoma Recruiting
University of Texas Southwestern Medical Center Dallas Texas Recruiting
ANESC Research El Paso Texas Recruiting
Saturn Research Solutions Plano Texas Recruiting
University of the Sunshine Coast Clinical Trials Birtinya Queensland Recruiting
North Bristol NHS Trust - Southmead Hospital Bristol United Kingdom Recruiting
Cardiff and Vale University Health Board - University Hospital Wales Cardiff United Kingdom Recruiting
Anne Rowling Regenerative Neurology Clinic, University of Edinburgh Edinburgh United Kingdom Recruiting
NHS Greater Glasgow & Clyde - Institute of Neurological Sciences Glasgow United Kingdom Recruiting
Cambridge Clinical Research Centre London United Kingdom Recruiting
East Kent Hospitals University NHS Foundation Trust London United Kingdom Recruiting
The Newcastle Upon Tyne Hospitals NHS Foundation Trust Newcastle upon Tyne United Kingdom Recruiting
Sheffield Teaching Hospital NHS foundation Trust, Herries Road Sheffield United Kingdom Recruiting

More ModernaTX, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06735248 on ClinicalTrials.gov ↗ ← All trials in the USA