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

Phase 2

Not yet recruiting

• Conditions: Early Multiple Sclerosis; Multiple Sclerosis
• Interventions: Biological: mRNA-1195; Biological: Placebo

• Registration Number: NCT06735248
• Lead Sponsor: ModernaTX, Inc.

Brief Summary

The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-11
• Study First Posted: 2024-12-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Study Start: 2025-04-28
• Primary Completion: 2029-01-08
• Study Completion: 2029-01-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Medically stable as determined by Investigator's medical evaluation, which will include assessment of medical history, physical examination, laboratory testing, and cardiac monitoring.
• Participants who are Epstein-Barr virus (EBV)-seropositive at screening.
• Participants who could become pregnant.

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 the Day 1 study injection, or within 14 days before or after Day 1 study intervention 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 for >14 consecutive days within the 30 day period prior to screening (for corticosteroids, ≥10 milligrams (mg)/day of prednisone or equivalent)
• 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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
mRNA-1195 Dose Level 1 (Low Dose)	mRNA-1195	Participants will receive 3 intramuscular (IM) injections at dose level 1 (low dose) on a 0-, 2-, and 6-month schedule.
mRNA-1195 Dose Level 2 (High Dose)	mRNA-1195	Participants will receive 3 IM injections at dose level 2 (high dose) on a 0-, 2-, and 6-month schedule.
Placebo	Placebo	Participants will receive 3 placebo IM injections on a 0-, 2-, and 6-month schedule.

Primary Outcome Measures

Name	Time	Method
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 Solicited Local and Systemic Adverse Reactions (ARs)	Up to Day 176 (7 days after each 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 Outcome Measures

Name	Time	Method
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	Baseline, Month 12
Cumulative Number of New Gd-enhancing T1 Hyperintense Lesions, as Measured by MRI from Baseline to End of Study (Day 887)	Baseline, Day 887 (end of study)
Mean Number of Gd-enhancing T1 Hyperintense Lesions Per Scan, as Measured by MRI from Baseline to Month 12	Baseline, Month 12
Mean Number of Gd-enhancing T1 Hyperintense Lesions Per Scan, as Measured by MRI from Baseline to End of Study (Day 887)	Baseline, 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	Baseline, Month 12
Cumulative Number of New and/or Newly Enlarging T2-weighted Hyperintense Lesions as Measured by MRI from Baseline to End of Study (Day 887)	Baseline, 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
Geometric Mean Fold Rise (GMFR) of B-cell nAbs and/or Vaccine Antigen-specific bAbs at Days 1, 85, and 197	Days 1, 85, and 197
Change in Expanded Disability Status Scale (EDSS) Score at 3- and 6-month Intervals from Baseline to End of Study (Day 887)	Baseline, Day 887 (end of study)
Time to 6-month Confirmed Disability Progression	Up to Day 887 (end of study)