Last updated on May 2019

Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab


Brief description of study

The study will provide efficacy, safety, tolerability and pharmacokinetics data for ofatumumab 20 mg subcutaneous injections every 4 weeks compared with placebo for 24 weeks in patients from Japan and the other countries and also provide the extended efficacy, safety, tolerability and pharmacokinetics data.

Detailed Study Description

This study has 2 parts: A controlled Core and an open-label Extension.

  • Core part: A 24-week, randomized, double-blind, placebo controlled, parallel-group, multicenter study to evaluate the efficacy, safety and tolerability and PK of ofatumumab in patients with relapsing MS.
  • Extension part: The Core part is followed by an Extension part in which all patients receive open-label ofatumumab. In the Extension part, patients are treated for at least 24 weeks and no longer than 48 weeks.

Approximately 60 patients will be randomized in a 2:1 ratio to ofatumumab or placebo in the Core part; half of the study patients will be from Japan and the other half from the other countries.

Clinical Study Identifier: NCT03249714

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Recruitment Status: Open


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