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A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Oral BIIB061 as Add-On Therapy to Interferon-Beta 1 or Glatiramer Acetate Therapies in Relapsing Multiple Sclerosis

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A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Oral BIIB061 as Add-On Therapy to Interferon-Beta 1 or Glatiramer Acetate Therapies in Relapsing Multiple Sclerosis

Status: Withdrawn prior to enrolment
Phase of Trial: Phase II

Latest Information Update: 05 Jun 2023

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At a glance

  • Drugs BIIB 061 (Primary) ; Glatiramer acetate; Interferon beta-1
  • Indications Multiple sclerosis
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Biogen

    • Most Recent Events

    • 31 May 2023 Status changed from not yet recruiting to withdrawn prior to enrolment based on lack of stronger preclinical effects of BIIB061 on remyelination relative to opicinumab, that showed limited clinical efficacy in phase 2 clinical studies. This was not related to safety concerns.
    • 24 Nov 2020 Planned End Date changed from 18 Jul 2023 to 18 Sep 2024.
    • 24 Nov 2020 Planned primary completion date changed from 18 Jul 2023 to 18 Sep 2024.

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