About the RACEMATE trial
What is the RACEMATE trial?
RACEMATE is an acronym for “A RAndomised Placebo Controlled Trial - to Explore the Efficacy and Mechanism of Action of Tezepelumab in Eosinophilic Granulomatosis with Polyangiitis”. The study includes 2 main parts: one investigating the effect of treatment on disease activity and the second analysing the effect of treatment on samples taken from the lung (bronchoscopy sub-study).
What is the purpose of the RACEMATE trial?
RACEMATE has been designed to investigate whether Tezepelumab can increase the chance of remission (this is defined as the absence of active or new disease features) for adults with Eosinophilic Granulomatosis with Polyangiitis (EGPA). The study will also aim to identify in greater detail how the drug works by taking relevant samples before, during and after treatment with the drug or a matching placebo (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.
What is EGPA?
EGPA is a rare chronic multisystem disease characterised by asthma, sinusitis, high levels of eosinophils (a type of white blood cell that helps fight certain infections and play a key role in allergy), 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.
What is Tezepelumab?
Tezepelumab is a biologic medicine shown to significantly reduce asthma exacerbation rate in patients with severe asthma. 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. 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 there is an increased likelihood of achieving remission of EGPA.
Why is the RACEMATE trial important?
There are few effective therapies for EGPA and only two biologics (Mepolizumab and Benralizumab) are currently licensed for use specifically in this condition (in the EU and US). However, in the clinical trial where this drug was investigated, approximately half the patients did not achieve disease remission. Furthermore, there are currently no licensed targeted treatments for EGPA in the UK, thus there is a significant need for investigation and further trials in this area. We aim to address this with RACEMATE.
What happens during the trial?
The trial aims to recruit 66 participants throughout the UK and Italy. The study will last 32 weeks, with 9 visits in total. The participant will obtain 7 doses of Tezepelumab or placebo, administered monthly over 6 months.
Trial design
The trial will compare participants treated with Tezepelumab with participants given a placebo. A placebo is not an active medicine, and there will be a 50% chance of obtaining the placebo. The participant, research nurse and doctor will not know whether the participant is given Tezepelumab or placebo, the chance of obtaining Tezepelumab or placebo will be performed randomly via computer.
A subgroup of consenting trial participants will be enrolled into a bronchoscopy sub study to determine if there are any changes in immune cell properties.
Study assessments will also include questionnaires, lung function, blood tests, electrocardiograms (ECGs), urine tests, vital signs and physical examination in all study participants.
Participants can withdraw at any time, without providing a reason.
Where is the RACEMATE trial taking place?
RACEMATE is due to enrol across 11 UK sites:
- Imperial College Healthcare NHS Trust
- Guy’s & St Thomas’ Hospital NHS Foundation Trust (including Royal Brompton Hospital)
- Royal Free London NHS Foundation Trust
- Cambridge University Hospitals NHS Foundation Trust
- University Hospitals of Leicester NHS Trust
- Liverpool University Hospitals NHS Foundation Trust
- Aberdeen Royal Infirmary – NHS Grampian
- Royal Infirmary of Edinburgh – NHS Lothian
- University Hospitals Birmingham NHS Foundation Trust
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Barts Health NHS Trust