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
ModernaTX, Inc.
Summary
The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis.
Eligibility
- Age range
- 18–55 years
- Sex
- All
- 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…
Interventions
- BiologicalmRNA-1195
IM injection
- BiologicalPlacebo
IM injection
Locations (17)
- Boston Clinical Trials Inc - Internal MedicineBoston, Massachusetts
- Quest Research InstituteFarmington Hills, Michigan
- Sharlin Health & NeurologyOzark, Missouri
- Washington University School of Medicine Neurology Clinical UnitSt Louis, Missouri
- Oklahoma Medical Research Foundation (OMRF) MS Center of ExcellenceOklahoma City, Oklahoma
- University of Texas Southwestern Medical CenterDallas, Texas