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A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab

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Trial Profile

A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 28 Nov 2023

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At a glance

  • Drugs Ofatumumab (Primary)
  • Indications Multiple sclerosis
  • Focus Therapeutic Use
  • Acronyms APOLITOS
  • Sponsors Novartis; Novartis Pharmaceuticals

    • Most Recent Events

    • 13 Oct 2023 Results assessing the effect of ofatumumab on serum IgG/IgM levels up to 5 years during the core and open-label extension studies (ASCLEPIOS I/II, APOLITOS, APLIOS & ALITHIOS) presented at the 9th Triennial joint meeting of Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis.
    • 27 Apr 2023 Results assessing compliance and persistence with ofatumumab in patients with relapsing multiple sclerosis for up to 4 years from fatumumab studies and the ALITHIOS extension study presented at the 75th Annual Meeting of the American Academy of Neurology 2023
    • 28 Jun 2022 Results assessing the cumulative safety data for up to 4 years with ofatumumab (cut-off: 25-Sep-2021) in the overall (n=1,969), continuous (ofatumumab in core+extension; n=1,292) and newly- switched (teriflunomide core and ofatumumab extension; n=677) groups in patients completing the core ASCLEPIOS I/II, APOLITOS and APLIOS trials could enter ALITHIOS studies, presented at the 8th Congress of the European Academy of Neurology.
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