* NEOS

• Research type

  Research Study

• Full title

  A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021

• IRAS ID

  1004421

• Contact name

  Claus-Peter Danzer

• Contact email

  claus-peter.danzer@novartis.com

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2020-002700-39

• Clinicaltrials.gov Identifier

  NCT04926818

• Research summary

  The main purpose of the study is to find out if ofatumumab and siponimod are safe and beneficial to use in children/adolescents with MS aged 10 to 17 at the start of the study. We know fingolimod works well in children and in adults; we also know ofatumumab and siponimod work well in adults. We want to learn if ofatumumab and siponimod work well in children/adolescents; this means to find out if patients treated with either ofatumumab or siponimod may experience fewer, more or same number of MS relapses (also called clinical attacks, exacerbations or flare ups) than patients treated with fingolimod (Gilenya®), which is an approved medication for the treatment of relapsing forms of MS in adults and in children 10 years of age and older.
  Multiple sclerosis (MS) is an immune-mediated disease of the central nervous system which can cause severe disability. The immune system is made up of many different types of cells that work together to fight infection. Lymphocytes, which are a type of white blood cell, are important in the immune response against infections. Lymphocytes include subsets of cells called B cells and T cells.
  During the clinical attacks/relapses, your own immune system attacks the nerves in the brain or spinal cord, damaging the myelin covering. This can result in symptoms including difficulties in walking, balance problems, vision problems, and abnormal MRI results.
  All three medications, ofatumumab, siponimod and fingolimod, target cells in the immune system to reduce MS disease activity, however, the way they do this differs from each other.
  This study, also called NEOS, will look at how well ofatumumab and siponimod are also working in children with MS compared to fingolimod, which is used in the study as the comparator drug.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  21/FT/0164

• Date of REC Opinion

  28 Jan 2022

• REC opinion

  Further Information Favourable Opinion