mRNA-1195 for Multiple Sclerosis

Overseen By Moderna WeCare Team

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: ModernaTX, Inc.

Must not be taking: Systemic immunosuppressants

Disqualifiers: Fever, Unstable condition, Myocarditis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 6 months

180 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for adults aged 18 to 55 with multiple sclerosis who are medically stable, have had a positive test for Epstein-Barr virus (EBV), and could potentially become pregnant. Participants must pass a medical evaluation including history review, physical exam, lab tests, and heart monitoring.

Inclusion Criteria

I am capable of becoming pregnant.

I have tested positive for the Epstein-Barr virus.

My doctor confirms my health is stable enough for a clinical trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 intramuscular injections of mRNA-1195 or placebo on a 0-, 2-, and 6-month schedule

6 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• mRNA-1195

Trial Overview The study is testing mRNA-1195's ability to prevent relapses in multiple sclerosis compared with a placebo. The main goal is to check the safety of mRNA-1195 and how participants' bodies react to it.

Participant Groups

Group I: mRNA-1195 Dose Level 2 (High Dose) Experimental Treatment 1 Intervention

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

Group II: mRNA-1195 Dose Level 1 (Low Dose) Experimental Treatment 1 Intervention

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

Group III: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

ModernaTX, Inc.

Lead Sponsor

Trials

127

Recruited

66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris