RACEMATE

• Research type

  Research Study

• Full title

  RAndomised Placebo Controlled Trial - to Explore the Efficacy and Mechanism of Action of Tezepelumab in Eosinophilic Granulomatosis with Polyangiitis (RACEMATE)

• IRAS ID

  1007564

• Contact name

  Salman Siddiqui

• Contact email

  s.siddiqui@imperial.ac.uk

• Sponsor organisation

  Imperial College London, Research Governance and Integrity Team (RGIT)

• Research summary

  The study is being carried out to investigate whether a drug, Tezepelumab, can increase the chance of Eosinophilic granulomatosis with polyangiitis (EGPA)being in remission (this is defined as the absence of active or new disease features), as well as finding out how the drug works by taking relevant samples before, during and after treatment with the drug or a matching placebo. A placebo is an inactive substance that looks like the drug or treatment being tested. Comparing results from the two groups suggests whether changes in the test group result from the treatment or occur by chance.
  EGPA is a condition characterised by asthma, high levels of eosinophils (a type of white blood cell that helps fight infection), and inflammation of small to medium sized blood vessels (vasculitis). The inflamed vessels can affect various organ systems including the lungs, gastrointestinal tract, skin, heart, and nervous system. The exact cause of Eosinophilic granulomatosis with polyangiitis is unknown, but it is thought to be an autoimmune disorder.

  We have focused on Tezepelumab because it has already been shown to reduce severe exacerbations of asthma and in pre-clinical models of EGPA there is evidence that molecules like TSLP might be important in causing active disease. Tezepelumab targets a protein that is found in patients with EGPA, (called Thymic Stromal Lymphopoietin - TSLP). This protein is an alarm signal in the airway and information from pre-clinical models of EGPA suggests that alarm signal proteins (called ‘alarmins’) are important in causing vasculitis. By targeting this protein, we believe that this will be more likely to achieve remission of EGPA.

  The study will randomly assign people to one of two groups (drug: tezepelumab or placebo). The RACEMATE study is designed as a ‘double blind’ study. There will be 62 people taking part, from upto 20 specialist hospitals in the United Kingdom.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  23/NW/0270

• Date of REC Opinion

  17 Nov 2023

• REC opinion

  Further Information Favourable Opinion