215ON201: Study of BIIB033 in subjects with acute optic neuritis

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With First Episode of Acute Optic Neuritis

• IRAS ID

  112950

• Contact name

  Gordon Plant

• Sponsor organisation

  Biogen Idec Research Ltd

• Eudract number

  2011-006291-39

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a phase 2 randomised, placebo-controlled efficacy and safety study of BIIB033. The purpose of this study is to find out if a new investigational drug called BIIB033 is safe and effective in treating patients with their first episode of Acute Optic Neuritis (AON). BIIB033 belongs to a class of drugs known as humanized monoclonal antibodies that attach to cells and change how they work or communicate with other cells. Approximately 80 people with AON will be treated at 30 to 40 study sites in North America, Europe, and Australia. Approximately 12 participants are expected to be recruited in the UK. The duration of participation is expected to be 36 weeks (approximately 9 months). The study will consist of: - Screening Period of 1 to 28 days - 20 week Treatment Period - 4 week End of Treatment Period - 8 week End of Study/Follow-Up Period Participants will be randomised (1:1) to one of 2 treatment groups: ?½ Group 1: BIIB033 at a dose of 100 mg/kg given as an intravenous (IV) infusion every 4 weeks. ?½ Group 2: Placebo given as an intravenous (IV) infusion every 4 weeks. This study involves procedures including: physical examination, vital signs, ECG, blood tests, urine tests MRI, vision tests and questionnaires. The study is funded by Biogen Idec.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  12/SC/0527

• Date of REC Opinion

  12 Nov 2012

• REC opinion

  Further Information Favourable Opinion