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Ofatumumab approved dose

Phase 3

Relapsing Multiple Sclerosis (RMS) | Monoclonal antibody | Immunology |Novartis AG|Last Updated: May 12, 2026

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
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment196
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06869785Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of OfatumumabPHASE3 ACTIVE NOT_RECRUITING 196Mar 13, 2025Mar 23, 2030May 12, 202665 United States, Puerto Rico
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Study Endpoints
Primary Endpoints
Ofatumumab plasma pharmacokinetics - area under the curve
Up to 12 weeks
Secondary Endpoints
Ofatumumab plasma pharmacokinetics - minimum observed plasma concentration
Up to 12 weeks
Ofatumumab plasma pharmacokinetics - maximum observed plasma concentration
Up to 12 weeks
Incidence of Adverse events (AE) and Serious adverse events (SAE)
Up to 52 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Ofatumumab dose 1ACTIVE_COMPARATORApproved dosage
Ofatumumab dose 2EXPERIMENTALNew dosage
Interventions
NameTypeDescription
Ofatumumab approved doseBIOLOGICALApproved dosage
Ofatumumab new doseBIOLOGICALNew dosage
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Eligibility Criteria
Age Range18 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites65

Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Male or female study participants aged 18 to 60 years (inclusive) at screening. * Diagnosis of multiple sclerosis (MS) according to the 2017 Revised McDonald criteria (Thompson et al 2018). Relapsi...

Countries:United StatesPuerto Rico
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06869785primaryCompletionDate: changed
LOWMay 24, 2026NCT06869785studyFirstPostDate: changed