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

Moderna

Status and phase: Enrolling; Phase 2

Conditions: Multiple Sclerosis

Treatments: Biological: mRNA-1195; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06735248

2024-517949-13-00 (Other Identifier)

mRNA-1195-P201

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

---

180 participants in 3 patient groups, including a placebo group

mRNA-1195 Dose Level 1 (Low Dose)

Experimental group

Description:

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

Treatment:

Biological: mRNA-1195

mRNA-1195 Dose Level 2 (High Dose)

Experimental group

Description:

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

Treatment:

Biological: mRNA-1195

Placebo

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo