Recent Updates
Recently added Catalysts

mRNA-1195

Phase 2

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

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
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 Sclerosis
NCT06735248180
Unlock 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)
Unlock Study Endpoints
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
Unlock Study Design Details
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
Unlock Eligibility Criteria
Competitive Landscape -Multiple Sclerosis 97 trials

Top 20 of 21 competitors

CompanyTickerTrialsLead PhaseDrugs
Sanofi SA Sponsored ADRSNY6PHASE3Frexalimab, MRI contrast-enhancing agents
Bristol-Myers Squibb CompanyBMY8PHASE3Ozanimod, Fingolimod
Novartis AG Sponsored ADRNVS23PHASE3Remibrutinib, Teriflunomide
Biogen Inc.BIIB6PHASE3BIIB017, Interferon beta type 1a
Zenas BioPharma, Inc.ZBIO3PHASE3Orelabrutinib
TG Therapeutics, Inc.TGTX8PHASE3Ublituximab
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
Hoffmann-La RocheRHHBY1PHASE3Ocrelizumab, Fingolimod
Tiziana Life Sciences Ltd.TLSA2PHASE2Foralumab
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
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE1Obecabtagene autoleucel
TScan Therapeutics, Inc.TCRX1 - Undisclosed
Merck & Co., Inc.MRK1 - Mavenclad
Solana Company Class AHSDT1 - Undisclosed
Unlock Competitive Intelligence
Recent Changes (Last 90 Days)
LOWJun 16, 2026NCT06735248lastUpdatePostDate: changed
LOWJun 16, 2026NCT06735248lastUpdatePostDate: changed
LOWJun 16, 2026NCT06735248lastUpdatePostDate: changed
LOWJun 16, 2026NCT06735248lastUpdatePostDate: changed
LOWMay 26, 2026NCT06735248primaryCompletionDate: changed
LOWMay 24, 2026NCT06735248studyFirstPostDate: changed