Multiple SclerosisPhase 2NCT06735248
A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years
A Phase 2 study testing mRNA-1195 in people with Multiple Sclerosis, run by ModernaTX, Inc. at 17 sites in 3 countries.
Trial summary
The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- mRNA-1195
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 16 Apr 2025to 8 Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
17 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 3 countries
United States8 sites, 6 recruiting
- Terminated
Boston Clinical Trials Inc - Internal Medicine
Boston, Massachusetts, 02131
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-8806
- Recruiting
ANESC Research
El Paso, Texas, 79912
Frank Chairz, 915-974-2200 ext. 3, fchairez@anesc.net
Aamr Herekar, MD
- Recruiting
Quest Research Institute
Farmington Hills, Michigan, 48334
- Recruiting
Oklahoma Medical Research Foundation (OMRF) MS Center of Excellence
Oklahoma City, Oklahoma, 73104
- Terminated
Sharlin Health & Neurology
Ozark, Missouri, 65721
- Recruiting
Saturn Research Solutions
Plano, Texas, 75024
- Recruiting
Washington University School of Medicine Neurology Clinical Unit
St Louis, Missouri, 63110
United Kingdom8 sites, 8 recruiting
- Recruiting
North Bristol NHS Trust - Southmead Hospital
Bristol, BS10 5NB
- Recruiting
Cardiff and Vale University Health Board - University Hospital Wales
Cardiff, CF14 4XW
- Recruiting
Anne Rowling Regenerative Neurology Clinic, University of Edinburgh
Edinburgh, EH16 4SB
- Recruiting
NHS Greater Glasgow & Clyde - Institute of Neurological Sciences
Glasgow, G51 4TF
- Recruiting
Cambridge Clinical Research Centre
London, CB2 0SL
- Recruiting
East Kent Hospitals University NHS Foundation Trust
London, CT1 3NG
- Recruiting
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE14LP
- Recruiting
Sheffield Teaching Hospital NHS foundation Trust, Herries Road
Sheffield, S10 2JF
Australia1 site, 1 recruiting
- Recruiting
University of the Sunshine Coast Clinical Trials
Birtinya, Queensland, 04575
About this study
Official title: A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of mRNA-1195 Intramuscular Injection in Participants 18 to ≤55 Years of Age With Multiple Sclerosis
The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis.
- Conditions
- Multiple Sclerosis
- Being tested
- mRNA-1195, Placebo
- Keywords
- Multiple Sclerosis, mRNA-1195, MS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1195Biological
IM injection
PlaceboBiological
IM injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: mRNA-1195 |
| Placebo | Placebo comparator | Participants will receive 3 placebo IM injections on a 0-, 2-, and 6-month schedule. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Measured: Up to Day 176 (7 days after each study injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Measured: Up to Day 197 (28 days after each study injection)
Number of Participants with Medically Attended Adverse Events (MAAEs)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Baseline, Day 887 (end of study)
Time to 6-month Confirmed Disability Progression
Measured: Up to Day 887 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start16 Apr 2025
- Primary completion8 Jan 2029 (estimated)
- Study completion8 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735248
- Sponsor's protocol ID
- mRNA-1195-P201
- Other IDs
- 2024-517949-13-00
- Status last verified
- Jun 2026
- First submitted
- 11 Dec 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of mRNA-1195 Intramuscular Injection in Participants 18 to ≤55 Years of Age With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06735248
- Acronym / sponsor ID
- mRNA-1195-P201
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, mRNA-1195, MS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 8 Jan 2029 (estimated)
- Study completion
- 8 Jan 2029 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mRNA-1195 Dose Level 1 (Low Dose) | Experimental | Biological: mRNA-1195Participants 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) | Experimental | Biological: mRNA-1195Participants will receive 3 IM injections at dose level 2 (high dose) on a 0-, 2-, and 6-month schedule. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants will receive 3 placebo IM injections on a 0-, 2-, and 6-month schedule. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-1195IM injection | Biological | mRNA-1195 Dose Level 1 (Low Dose), mRNA-1195 Dose Level 2 (High Dose) |
| PlaceboIM injection | Biological | Placebo |
Primary outcome
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to Day 176 (7 days after each study injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 197 (28 days after each study injection)
Number of Participants with Medically Attended Adverse Events (MAAEs)
Time frame: 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
Time frame: Up to Day 887 (end of study)
8 secondary outcomes
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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Baseline, Day 887 (end of study)
Time to 6-month Confirmed Disability Progression
Time frame: Up to Day 887 (end of study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mRNA-1195 in people with Multiple Sclerosis, run by ModernaTX, Inc. at 17 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, United Kingdom, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moderna WeCare Team (1-866-663-3762, WeCareClinicalTrials@modernatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) (time frame: Up to Day 176 (7 days after each study injection)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.