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mRNA-1195

Phase 2

Multiple Sclerosis | Monoclonal antibody | Immunology |Moderna, Inc.|Last Updated: Dec 22, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment180
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06735248A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 YearsPHASE2 RECRUITING 180 — — Apr 16, 2025Jan 8, 2029Dec 22, 202517 United States, Australia +1
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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 — 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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Competitive Landscape -Multiple Sclerosis 98 trials
CompanyTickerTrialsLead PhaseDrugs
Sanofi SA Sponsored ADRSNY6PHASE3Frexalimab, MRI contrast-enhancing agents, Tolebrutinib, Teriflunomide, Cholestyramine
Novartis AG Sponsored ADRNVS23PHASE3Remibrutinib, Teriflunomide, Fingolimod, Ofatumumab, Siponimod
Biogen Inc.BIIB6PHASE3BIIB017, Interferon beta type 1a, Diroximel, Dimethyl, Fingolimod
Bristol-Myers Squibb CompanyBMY8PHASE3Ozanimod, Fingolimod, BMS-986368, CC-97540, Fludarabine
TG Therapeutics, Inc.TGTX8PHASE3Ublituximab, Fingolimod
Zenas BioPharma, Inc.ZBIO3PHASE3Orelabrutinib, Obexelimab
Immunic, Inc.IMUX3PHASE3IMU-838
Amgen Inc.AMGN1PHASE3Ocrelizumab, ABP 692
Eli Lilly and CompanyLLY1PHASE2LY3541860
Moderna, Inc.MRNA1PHASE2mRNA-1195
Kyverna Therapeutics, Inc.KYTX3PHASE2KYV-101, Standard lymphodepletion regimen, Anti-CD20 mAB, KYV-101 - 0.33 ×10^8 cells, KYV-101 - 1 ×10^8 cells
Tiziana Life Sciences Ltd.TLSA2PHASE2Foralumab TZLS-401 100 µg, Foralumab
Supernus Pharmaceuticals, Inc.SUPN1PHASE2Phase 2; Low Dose MYOBLOC, Phase 3; MYOBLOC
AstraZeneca PLCAZN1PHASE1AZD0120 - Regimen 1, AZD0120 - Regimen 2
Gilead Sciences, Inc.GILD1PHASE1KITE-363, Fludarabine, Cyclophosphamide
Cabaletta Bio, Inc.CABA1PHASE1CABA-201
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE1Obecabtagene autoleucel
TScan Therapeutics, Inc.TCRX1 — Undisclosed
Merck & Co., Inc.MRK1 — Mavenclad
Solana Company Class AHSDT1 — Undisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06735248primaryCompletionDate: changed
LOWMay 24, 2026NCT06735248studyFirstPostDate: changed