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Ofatumumab approved dose

Phase 3

Relapsing Multiple Sclerosis (RMS) | Monoclonal antibody | Neurology |Novartis AG|Last Updated: Aug 10, 2026

Target and mechanism

Molecular targetMS4A1
Target classBinding Agent
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment196

FDA Designations

No designations recorded

Clinical trial landscape

Ofatumumab approved dose · 1 trial · 1 indication

Phase 3 1
NCT06869785Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of OfatumumabRelapsing Multiple Sclerosis (RMS)
ACTIVE NOT_RECRUITING196 Analytics
PHASE3ACTIVE NOT_RECRUITING
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab
Relapsing Multiple Sclerosis (RMS)Unlock trial analytics

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 to 100 Years
SexALL
Healthy VolunteersNo
Study Sites63

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)

LOWAug 11, 2026NCT06869785lastUpdatePostDate: changed
LOWAug 11, 2026NCT06869785lastUpdatePostDate: changed
LOWAug 11, 2026NCT06869785lastUpdatePostDate: changed

Frequently asked questions about Ofatumumab approved dose

What is Ofatumumab approved dose used for?

Ofatumumab approved dose is a monoclonal antibody being developed for relapsing multiple sclerosis (RMS). It is currently in Phase 3 clinical development and is being studied in a trial that includes patients with RMS. The drug is administered as a maintenance dosing regimen.

Who makes Ofatumumab approved dose?

Ofatumumab approved dose is being developed by Novartis AG, which trades under the ticker NVS. The company is conducting a Phase 3 clinical trial to evaluate the drug in patients with relapsing multiple sclerosis.

What phase is Ofatumumab approved dose in?

Ofatumumab approved dose is in Phase 3 clinical development. It is being studied in an active-controlled trial for relapsing multiple sclerosis, with the trial currently active but not recruiting participants.

What clinical trials is Ofatumumab approved dose in?

Ofatumumab approved dose is being evaluated in a Phase 3 trial with the identifier NCT06869785. This trial is studying the pharmacokinetics, pharmacodynamics, safety, and tolerability of a new maintenance dosing regimen of ofatumumab in patients with relapsing multiple sclerosis.

What does Ofatumumab approved dose target?

Ofatumumab approved dose is a monoclonal antibody, which is a type of -mab antibody. As an antibody-based therapy, it is designed to interact with specific targets in the immune system, though the specific molecular target is not detailed here.

Is Ofatumumab approved dose the same as ofatumumab?

Ofatumumab approved dose is a specific formulation or dosing regimen of ofatumumab, which is being studied for relapsing multiple sclerosis. The name indicates it is an approved dose of ofatumumab, but the drug is still in clinical development for this indication.