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A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients

Trial Profile

A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients

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 Pharmacokinetics
  • Acronyms APLIOS
  • 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.
    • 19 Dec 2022 Results assessing the temporal association between sNfL and development of subclinical disease activity as assessed by magnetic resonance imaging, published in the Neurology and Therapy
    • 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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