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mRNA-1195

Phase 2

Multiple Sclerosis | Monoclonal antibody | Neurology |Moderna, Inc.|Last Updated: Jun 15, 2026

Target and mechanism

Molecular targetEBV
Target classVirus
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment180

FDA Designations

No designations recorded

Clinical trial landscape

mRNA-1195 · 1 trial · 1 indication

Phase 2 1
NCT06735248A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 YearsMultiple Sclerosis
RECRUITING180 Analytics
PHASE2RECRUITING
A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years
Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

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 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 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 Endpoints

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)
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)
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)
Baseline to Month 12 and Day 887 (end of study)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
mRNA-1195 Dose Level 1 (Low Dose)EXPERIMENTALParticipants 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)EXPERIMENTALParticipants will receive 3 IM injections at dose level 2 (high dose) on a 0-, 2-, and 6-month schedule.
PlaceboPLACEBO_COMPARATORParticipants will receive 3 placebo IM injections on a 0-, 2-, and 6-month schedule.

Interventions

NameTypeDescription
mRNA-1195BIOLOGICALIM injection
PlaceboBIOLOGICALIM injection
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites17

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)-seroposit...

Countries:United StatesAustraliaUnited Kingdom
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Recent Changes (Last 90 Days)

LOWJun 16, 2026NCT06735248lastUpdatePostDate: changed
LOWJun 16, 2026NCT06735248lastUpdatePostDate: changed
LOWJun 16, 2026NCT06735248lastUpdatePostDate: changed
LOWJun 16, 2026NCT06735248lastUpdatePostDate: changed

Frequently asked questions about mRNA-1195

What is mRNA-1195 used for in multiple sclerosis?

mRNA-1195 is an investigational therapy being studied for relapse prevention in multiple sclerosis. It is currently in Phase 2 clinical development and is being evaluated in adults aged 18 to 55 years with the condition.

What does mRNA-1195 target?

mRNA-1195 targets the Epstein-Barr virus (EBV), a virus implicated in multiple sclerosis. By targeting EBV, the therapy aims to address a potential underlying trigger of the disease.

Who is developing mRNA-1195?

mRNA-1195 is being developed by Moderna, Inc., a biotechnology company publicly traded under the ticker symbol MRNA on the Nasdaq stock exchange.

What phase is mRNA-1195 in?

mRNA-1195 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being tested in clinical trials.

What clinical trials is mRNA-1195 in?

mRNA-1195 is being studied in a Phase 2 clinical trial with the identifier NCT06735248. The trial is recruiting participants with multiple sclerosis and is being conducted in the United States, Australia, and the United Kingdom.

Is mRNA-1195 the same as a monoclonal antibody?

mRNA-1195 is described as a monoclonal antibody modality, though its name suggests it may be an mRNA-based therapy. The clinical trial evaluates it against placebo in a randomized, double-blind design.