Phase 2 Study of mRNA-1195 Shots to Prevent Multiple Sclerosis Relapses in Adults 18 to 55 Years Old

What this Trial Is About

Researchers are evaluating the safety and immune response of mRNA-1195, a potential treatment for adults aged 18 to 55 with multiple sclerosis. The study focuses on participants who have relapsing multiple sclerosis or early signs of the disease and aims to understand how the treatment works compared to a placebo. This Phase 2 trial is sponsored by ModernaTX, Inc. and follows a randomized, observer-blind design to ensure reliable results. Participants are divided into three groups receiving either a low dose or high dose of mRNA-1195, or a placebo. Each participant receives three intramuscular injections scheduled at the start, two months, and six months. The study monitors participants for up to nearly four years, including follow-up for safety and disease progression. During the study, participants undergo regular assessments including MRI scans to monitor brain lesions, blood tests to measure immune response, and evaluations of disability progression. Researchers track side effects, adverse events, and overall health throughout the study period. The primary outcomes focus on safety reactions shortly after injections, while secondary outcomes assess changes in disease activity and immune response over time.

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