Efficacy and safety study of rozanolixizumab to treat severe fibromyalgia syndrome patients

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a, Proof-Of-Concept Study To Evaluate The Efficacy And Safety Of Rozanolixizumab To Treat Adult Study Participants With Severe Fibromyalgia Syndrome

• IRAS ID

  1006206

• Contact name

  Shikiko Watanabe

• Contact email

  Shikiko.watanabe@ucb.com

• Sponsor organisation

  UCB Biopharma SRL

• Eudract number

  2022-001523-32

• Clinicaltrials.gov Identifier

  NCT05643794

• Research summary

  The purpose of this study is to test a drug called rozanolixizumab (the ‘study drug’) that is being developed for the treatment of severe fibromyalgia syndrome. The body makes different antibodies (also called immunoglobulins), which are protective proteins produced by the immune system; antibodies help the body to fight different things, such as infections. Sometimes, the body mistakenly makes antibodies against itself, meaning the immune system treats healthy organs and tissues like foreign invaders and attacks them. This is called an autoimmune disease. The exact cause of fibromyalgia is unknown, but recently researchers in the UK and Sweden have reported some scientific evidence suggesting that severe fibromyalgia syndrome may be an autoimmune condition that is linked to an immunoglobulin (antibody) called IgG. IgG is the most common antibody in the blood circulation, and it helps protects against bacterial and viral infections.
  These findings suggest that some cases of severe fibromyalgia syndrome may be caused by the immune system producing IgG antibodies, leading to widespread pain. Therefore, lowering these IgG antibodies could be a potential treatment.
  The aim of this study is to assess whether the study drug will reduce levels of IgG antibodies in patients with severe fibromyalgia syndrome and improve their symptoms, as well as assessing its safety in these patients.
  The main aims of this study are:
  • To assess the safety and tolerability of the study drug
  • To assess the effect of the study drug on fibromyalgia syndrome
  • To see how the body absorbs and removes the study drug

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  22/NW/0275

• Date of REC Opinion

  11 Nov 2022

• REC opinion

  Further Information Favourable Opinion