Recruiting
Phase 2

mRNA-1195

Sponsor:

Moderna

Code:

NCT06735248

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

mRNA-1195

Placebo

Study Details

Brief summary:

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

Conditions

Multiple Sclerosis

Study ID

NCT06735248

Start date

Apr 16, 2025

Status verified date

Jun, 2026

Completion date

Jan 8, 2029

Anticipated

Primary completion date

Jan 8, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: mRNA-1195 Dose Level 1 (Low Dose)

Participants will receive 3 intramuscular (IM) injections at dose level 1 (low dose) on a 0-, 2-, and 6-month schedule.

experimental: mRNA-1195 Dose Level 2 (High Dose)

Participants will receive 3 IM injections at dose level 2 (high dose) on a 0-, 2-, and 6-month schedule.

placebo comparator: Placebo

Participants will receive 3 placebo IM injections on a 0-, 2-, and 6-month schedule.

Interventions

mRNA-1195

IM injection

Placebo

IM injection

Primary outcome measure

  • Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 176 (7 days after each study injection) ]
  • Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 197 (28 days after each study injection) ]
  • Number of Participants with Medically Attended Adverse Events (MAAEs) [ Time Frame: Up to Day 347 (up to 6 months after last study injection) ]
  • Number of Participants with Adverse Events of Special Interest (AESI), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention and/or Study Participation [ Time Frame: Up to Day 887 (end of study) ]

Central Contacts and Locations

Central contacts

Moderna WeCare Team

1-866-663-3762WeCareClinicalTrials@modernatx.com

Locations

Quest Research Institute

Recruiting

Farmington Hills, Michigan, United States, 48334

Washington University School of Medicine Neurology Clinical Unit

Recruiting

St Louis, Missouri, United States, 63110

Oklahoma Medical Research Foundation (OMRF) MS Center of Excellence

Recruiting

Oklahoma City, Oklahoma, United States, 73104

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390-8806

ANESC Research

Recruiting

El Paso, Texas, United States, 79912

Contacts

Frank Chairz

915-974-2200fchairez@anesc.net

Principal Investigator:

Aamr Herekar, MD

Saturn Research Solutions

Recruiting

Plano, Texas, United States, 75024

More Information

Sponsor

ModernaTX, Inc.

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • Multiple Sclerosis
  • mRNA-1195
  • MS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ModernaTX, Inc. on 2026-06-15.