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

NCT06735248 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: mRNA-1195-P2012024-517949-13-00
• Study Type: interventional
• Target: 180
• Locations: 3 countries
• Sites: 17

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

Keywords

Multiple Sclerosis; mRNA-1195; MS

Outcome Measures

Primary Outcomes (4)

• Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

  Up to Day 176 (7 days after each study injection)

• Number of Participants with Unsolicited Adverse Events (AEs)

  Up to Day 197 (28 days after each study injection)

• Number of Participants with Medically Attended Adverse Events (MAAEs)

  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

  Up to Day 887 (end of study)

Secondary Outcomes (8)

• Cumulative Number of New Gadolinium (Gd)-enhancing Longitudinal Relaxation Time (T1) Hyperintense Lesions, as Measured by Magnetic Resonance Imaging (MRI) from Baseline to Month 12 and End of Study (Day 887)

  Baseline to Month 12 and Day 887 (end of study)

• Mean Number of Gd-enhancing T1 Hyperintense Lesions Per Scan, as Measured by MRI from Baseline to Month 12 and End of Study (Day 887)

  Baseline to Month 12 and Day 887 (end of study)

• Cumulative Number of New and/or Newly Enlarging Transverse Relaxation Time (T2)-weighted Hyperintense Lesions as Measured by MRI from Baseline to Month 12 and End of Study (Day 887)

  Baseline to Month 12 and Day 887 (end of study)

• Time to First New Disease Activity on Study as Defined by a Clinical Attack Indicative of Central Nervous System (CNS) Involvement at a Site Remote to the First Attack or a New and/or Newly Enlarging T2 or Gd-enhancing Lesion on MRI

  Up to Day 887 (end of study)

• Geometric Mean Titer (GMT) of B-cell Neutralizing Antibodies (nAbs) and/or Vaccine Antigen-specific Binding Antibodies (bAbs) at Days 1, 85, and 197

  Days 1, 85, and 197

Study Arms (3)

mRNA-1195 Dose Level 1 (Low Dose)

EXPERIMENTAL

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

Biological: mRNA-1195

mRNA-1195 Dose Level 2 (High Dose)

EXPERIMENTAL

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

Biological: mRNA-1195

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

mRNA-1195 BIOLOGICAL

IM injection

mRNA-1195 Dose Level 1 (Low Dose); mRNA-1195 Dose Level 2 (High Dose)

Placebo BIOLOGICAL

IM injection

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (17)

Boston Clinical Trials Inc - Internal Medicine

Boston, Massachusetts, 02131, United States

RECRUITING

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

RECRUITING

Sharlin Health & Neurology

Ozark, Missouri, 65721, United States

RECRUITING

Washington University School of Medicine Neurology Clinical Unit

St Louis, Missouri, 63110, United States

RECRUITING

Oklahoma Medical Research Foundation (OMRF) MS Center of Excellence

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-8806, United States

RECRUITING

ANESC Research

El Paso, Texas, 79912, United States

RECRUITING

Saturn Research Solutions

Plano, Texas, 75024, United States

RECRUITING

University of the Sunshine Coast Clinical Trials

Birtinya, Queensland, 04575, Australia

RECRUITING

North Bristol NHS Trust - Southmead Hospital

Bristol, BS10 5NB, United Kingdom

RECRUITING

Cardiff and Vale University Health Board - University Hospital Wales

Cardiff, CF14 4XW, United Kingdom

RECRUITING

Anne Rowling Regenerative Neurology Clinic, University of Edinburgh

Edinburgh, EH16 4SB, United Kingdom

RECRUITING

NHS Greater Glasgow & Clyde - Institute of Neurological Sciences

Glasgow, G51 4TF, United Kingdom

RECRUITING

Cambridge Clinical Research Centre

London, CB2 0SL, United Kingdom

RECRUITING

East Kent Hospitals University NHS Foundation Trust

London, CT1 3NG, United Kingdom

RECRUITING

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE14LP, United Kingdom

RECRUITING

Sheffield Teaching Hospital NHS foundation Trust, Herries Road

Sheffield, S10 2JF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Moderna WeCare Team

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: April 16, 2025
• Primary Completion (Estimated): January 8, 2029
• Study Completion (Estimated): January 8, 2029
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

GB (8); US (8); AU (1)