cosMOG

• Research type

  Research Study

• Full title

  A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PHASE 3, PIVOTAL STUDY WITH AN OPEN-LABEL EXTENTION PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF ROZANOLIXIZUMAB IN ADULT PARTICIPANTS WITH MYELIN OLIGODENDROCYTE GLYCOPROTEIN (MOG) ANTIBODY-ASSOCIATED DISEASE (MOG-AD)

• IRAS ID

  1003956

• Contact name

  Tanja Webers

• Contact email

  Tanja.Webers@ucb.com

• Sponsor organisation

  UCB Biopharma SRL

• Eudract number

  2021-000352-19

• Clinicaltrials.gov Identifier

  NCT05063162

• Research summary

  MOG-AD is a condition that causes inflammation in the optic nerve (nerve that transmits impulses from the eye to the brain), spinal cord and brain. Symptoms will depend on the affected area (e.g., blurred vision and eye pain for optic neuritis, weakness in one or more limbs, tingling and sensory deficits in the spinal cord, or brain attacks). Symptoms of MOG-AD attack/relapse can be new or a worsening of previous symptoms, and they typically develop in the course of days during the acute attacks, and can resolve completely or only partially, leaving some ongoing symptoms.
  Currently, there are no approved treatments available for MOG-AD, but there are some treatments used to treat the relapse symptoms and others to prevent relapses but there is no consensus that any specific regimen is the most effective.
  Rozanolixizumab is an investigational drug that has not yet been approved for treatment by any health authorities globally for patients with MOG-AD. It is an antibody made to work as a medicine by reducing IgG antibodies which are involved in MOG-AD. Antibodies are substances in your body that help fight off certain infections, but can also be involved in immune disorders, such as MOG-AD.
  The purpose of MOG001 is to assess how safe, tolerable (acceptable to you) and effective rozanolixizumab is in treating MOG-AD. This study will help us understand how rozanolixizumab acts in your body and how your body reacts to it. In MOG001 study, half of the study participants will be given dummy drug (placebo) and half of the study participants will be given rozanolixizumab. However In case a relapse occurs, you will receive rescue medication and will all be allowed to receive rozanolixizumab.
  This study plans on including approximately 104 study participants from over 70 study sites across APAC, EMEA, Japan, NA & LATAM

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  21/SC/0391

• Date of REC Opinion

  2 Mar 2022

• REC opinion

  Further Information Favourable Opinion