mRNA-1195 for Multiple Sclerosis

Recruiting at 15 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called mRNA-1195 for people with multiple sclerosis (MS), focusing on its safety and effects on the body. The trial includes three groups: one receiving a low dose, another a high dose, and a third receiving a placebo (a substance with no active medication). It suits those diagnosed with relapsing MS who are stable and have received the diagnosis within the last two years. Participants must also test positive for the Epstein-Barr virus and be medically stable as assessed by a doctor. As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressants, you must stop them at least 30 days before screening.

Is there any evidence suggesting that mRNA-1195 is likely to be safe for humans?

Research has shown that mRNA-1195 is under study to determine its safety for people with multiple sclerosis. So far, most participants seem to tolerate this treatment well, though detailed information about side effects remains unavailable.

Since mRNA-1195 is in a Phase 2 trial, initial safety tests have already been conducted with people. Earlier studies for other conditions tested mRNA-1195 for safety, but more information is needed to understand its effects on individuals with multiple sclerosis.

Participants in this trial will receive injections of mRNA-1195 at varying doses to assess bodily responses. This process helps researchers ensure the treatment's safety and tolerability before broader use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple sclerosis?

Researchers are excited about mRNA-1195 for multiple sclerosis because it represents a novel approach using mRNA technology. Unlike traditional treatments like interferons or monoclonal antibodies, which target inflammation or the immune system broadly, mRNA-1195 works by instructing cells to produce specific proteins that may modulate the immune response more precisely. This targeted mechanism could potentially reduce disease activity with fewer side effects. Moreover, the use of mRNA technology opens the door to a more rapid development process and customization of therapies, offering hope for more personalized treatment options in the future.

What evidence suggests that mRNA-1195 might be an effective treatment for multiple sclerosis?

Research has shown that the Epstein-Barr virus (EBV) might trigger multiple sclerosis (MS) or worsen its symptoms. Most people with MS have EBV, and it likely plays a role in the condition. The mRNA-1195 treatment, which trial participants may receive at either a low or high dose, targets EBV and could help reduce MS flare-ups. Early results suggest that focusing on EBV might help manage MS, but more research is needed to confirm its effectiveness. This trial primarily aims to assess the safety of mRNA-1195, so further studies will be crucial to evaluate its effectiveness for MS. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06735248

NCT06735248 | A Study to Investigate Multiple Sclerosis ... The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis. Official Title. A Phase 2 ...

2. trials.modernatx.com trials.modernatx.com/study/?id=mRNA-1195-P201

A Clinical Trial of an Epstein-Barr Virus (EBV) Vaccine for ... EBV can trigger multiple sclerosis or make your symptoms worse. Most people with MS have EBV, and research shows that EBV is a contributing cause of MS.

3. withpower.com withpower.com/trial/phase-2-multiple-sclerosis-11-2024-2c56a

mRNA-1195 for Multiple Sclerosis 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 ...

4. ctv.veeva.com ctv.veeva.com/study/a-study-to-investigate-multiple-sclerosis-relapse-prevention-with-mrna-1195-compared-with-placebo-in

A Study to Investigate Multiple Sclerosis Relapse Prevention ... The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis.

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/13524585251340812?icid=int.sj-abstract.similar-articles.4

Considerations for Epstein-Barr virus vaccine-based ... A retrospective, real-world vaccine effectiveness study could be implemented to estimate the direct effects of EBV vaccination by comparing MS and other ...

6. connect.trialscope.com connect.trialscope.com/studies/311311d9-49e2-4cb3-8662-d0ed72a01e29

A clinical trial of an investigational Epstein-Barr virus (EBV ... The purpose of the Horizon Trial is to evaluate the safety and effectiveness of an investigational vaccine, called mRNA-1195, aimed at preventing EBV in adults ...