Not Authorised Therapeutic exploratory (Phase II) Eosinophilic granulomatosis with polyangiitis (EGPA)

A RAndomised Placebo Controlled Trial - to Explore the Efficacy and Mechanism of Action of Tezepelumab in EGPA- RACE-MATE

EU CTIS ID: 2024-514794-22-01

What this study is testing

RACEMATE is a phase 2b, multicentre, randomised, double-blinded, placebo-controlled study designed to explore the efficacy and mechanism of action of Tezepelumab in adults with eosinophilic granulomatosis with polyangiitis (EGPA). To compare the proportion of patients with EGPA that maintain remission over 24 weeks, in a randomised, double blind, multi-centre, placebo-controlled trial - comparing Tezepelumab to placebo.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Minimum Age: 18 Years Maximum Age: 75 Years Sex: All Gender Based: Accepts Healthy Volunteers: No Criteria: Inclusion Criteria: Capable of providing written informed consent Eosinophilic granulomatosis with polyangiitis is defined as a history of asthma, a blood eosinophil level of 10% or an absolute eosinophil count of more than 1.0 x10^9/L, and the presence of two or more criteria: - Histopathological evidence of eosinophilic vasculitis - Perivascular eosinophilic infiltration, or eosinophil-rich granulomatous inflammation - Neuropathy - Pulmonary infiltrate Sino-nasal abnormality Cardiomyopathy Glomerulonephritis Alveolar haemorrhage Palpable purpura Anti-neutrophil cytoplasmic antibody [ANCA] positivity History of one or more flares of EGPA in 24 months prior to screening. EGPA flares will be defined as worsening or persistence of active disease characterised by: - Active vasculitis (BVAS >0); OR - An asthma exacerbation/asthma worsening OR - Active nasal and/or sinus disease Warranting: - Rescue use of prednisolone for 3 or more days OR an increase in background prednisolone dose by at least 5 mg daily for at least three days OR - An increased dose or addition of immunosuppressive therapy; OR Hospitalisation related to EGPA worsening Blood eosinophil level at screening (visit 1) of ≥ 0.2 x10^9/L (participants can be re screened once within 2 weeks if the BEC is < 0.2 x10^9/L at the initial screening assessment). n.b. This criterion is not relevant for participants taking background anti-IL-5/5R biological agents mepolizumab (MEPO) or benralizumab (BRZ) in which any baseline blood eosinophil count (BEC) permitted. Non severe EGPA according to the American College of Rheumatology 2021 definition. Non-Severe EGPA: Vasculitis without life- or organ-threatening manifestations (e.g., rhinosinusitis, asthma, mild systemic symptoms, uncomplicated cutaneous disease, mild inflammatory arthritis). 6. Stable dose of prednisolone (≥5.0 to ≤30.0 mg per day, with or without additional Immunomodulatory therapy) for at least 4 weeks before the baseline visit. 7. Immunomodulatory therapy: (i) If receiving non-biologic immunomodulatory therapy, the dosage must be stable for the 4 weeks prior to baseline visit. (ii) Patients on background anti-IL-5/5R therapy (either MEPO or BRZ) at any licensed dose for the current clinical indications of severe asthma and EGPA in the UK and Europe respectively AND have been on treatment for at least 6 months. n.b. participants on background anti-IL-5/5R therapy will be capped to no more than 50% of the total sample size.

You likely can't join if

  • Diagnosis of Granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). Pregnancy or unable to use a highly effective method of birth control (confirmed by the Investigator) from randomisation throughout the study duration and within 8 weeks after last dose of IMP. Active life- or organ-threatening manifestations of EGPA within 6 months prior to screening, defined as: Severe alveolar haemorrhage Rapidly progressive glomerulonephritis Severe gastrointestinal or central nervous system involvement requiring intensification of immunosuppression or surgery Severe cardiac involvement including life threatening arrhythmia, heart failure with an ejection fraction < 20% or acute myocardial infarction or active myocarditis Current active malignancy. Immunodeficiency including HIV Helminth infection within 6-months of screening that has not been treated or remains refractory to treatment. Unstable liver disease with the exception of Gilberts syndrome or asymptomatic gallstones. Use of a prohibited concurrent medication as listed below: Biologic therapy for severe asthma (except MEPO or BRZ) within 4 months or 5 half-lives (whichever is longer) prior to Visit 1 or receipt of any investigational non-biologic agent within 30 days or 5 half-lives (whichever is longest) prior to Visit 1. Biologic therapies for EGPA including Rituximab and Alemtuzumab within 6 months of visit 1. IV or SC immunoglobulin therapy within 3 months of visit 1. Oral cyclophosphamide within 6 weeks of screening or IV cyclophosphamide within 4 months of visit 1. IM or IV corticosteroids within 6 weeks of visit 1. Known adrenal insufficiency (primary or secondary), that in the opinion of the investigator and clinical care team preclude maintenance oral steroid tapering

The study team makes the final eligibility decision.

Where it's taking place

  • United Kingdom

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.