This study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of a new dosage of ofatumumab compared to the approved dosage of ofatumumab followed by extended treatment in participants with relapsing multiple sclerosis.
This is a Phase 3, open label, parallel-group, multicenter study in participants with relapsing multiple sclerosis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
196
Approved dosage
New dosage
Ofatumumab plasma pharmacokinetics - area under the curve
Time frame: Up to 12 weeks
Ofatumumab plasma pharmacokinetics - minimum observed plasma concentration
Time frame: Up to 12 weeks
Ofatumumab plasma pharmacokinetics - maximum observed plasma concentration
Time frame: Up to 12 weeks
Incidence of Adverse events (AE) and Serious adverse events (SAE)
Time frame: Up to 52 weeks
Proportion of participants with anti-drug antibodies
Time frame: Up to 52 weeks
Participant B cell counts
Time frame: Up to 52 weeks
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