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EGPA - Eosinophilic Granulomatosis With PolyangiitisPhase 2RACEMATENCT06230354

Explore the Efficacy and Mechanism of Action of Tezepelumab in Eosinophilic Granulomatosis With Polyangiitis

A Phase 2 study testing Tezepelumab in people with EGPA - Eosinophilic Granulomatosis With Polyangiitis, run by Imperial College London at 12 sites in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Tezepelumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
12 sitesUnited Kingdom
Study dates
15 May 2024to Sep 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • Sino-nasal abnormality
  • Cardiomyopathy
  • Glomerulonephritis
  • Alveolar haemorrhage
  • Palpable purpura
  • Anti-neutrophil cytoplasmic antibody [ANCA] positivity
  • History of relapsing and refractory disease defined as:
  • Relapsing disease: One or more relapses of EGPA within 24 months prior to screening. EGPA relapses will be defined as worsening or recurrence 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
  • Refractory disease: Failure to attain remission (BVAS=0 AND OCS dose of prednisolone/prednisone ≤ 4 mg per day) on current standard of care treatment including patients on background anti-IL-5/IL-5Rα biological agents mepolizumab (MEPO) or benralizumab (BRZ) at any of the licensed doses for the current clinical indications of severe asthma and EGPA in the UK and Europe respectively.
  • 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/IL-5Rα 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).
  • 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.
  • Immunomodulatory therapy:
  • If receiving non-biologic immunomodulatory therapy, the dosage must be stable for the 4 weeks prior to baseline visit.
  • Patients on background anti-IL-5/IL-5Rα 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.

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United Kingdom12 sites

  • Aberdeen Royal Infirmary - NHS Grampian

    Aberdeen, AB25 2ZN

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2GW

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

  • Royal Infirmary of Edinburgh - NHS Lothian

    Edinburgh

  • Leeds Teaching Hospitals NHS Trust

    Leeds

  • University Hospitals of Leicester NHS Trust

    Leicester, LE3 9QP

  • Liverpool University Hospitals NHS Foundation Trust

    Liverpool, L7 8YE

  • Barts Health NHS Trust

    London, EC1A 7BE

  • Royal Free London NHS Trust

    London, NW3 2QG

  • Guy's Hospital - Guy's and St Thomas' NHS Foundation Trust

    London, SE1 9RT

  • Royal Brompton Hospital - Guy's and St Thomas' NHS Foundation Trust

    London, SW3 6NP

  • Imperial College Healthcare NHS Trust

    London, W2 1PG

Other trials in United Kingdom

About this study

Official title: A RAndomised Placebo Controlled Trial - to Explore the Efficacy and Mechanism of Action of Tezepelumab in Eosinophilic Granulomatosis With Polyangiitis

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).

Read the detailed description

RACEMATE is a randomised double-blind placebo-controlled experimental medicine study designed to explore both the efficacy and mechanism of action of tezepelumab (210 milligram [mg] administered subcutaneously [SC] every 4 weeks) compared with placebo over a 24-week study treatment period in subjects with active (non-severe) Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care therapy including background corticosteroid therapy with or without immunomodulatory therapy. This study will take place across 12 centres in the United Kingdom. Corticosteroid dose will be tapered during the treatment period in accordance with standard of care.

The key outcome of this study focuses on evaluation of clinical remission, defined as a Birmingham Vasculitis Activity Score (BVAS) version 3 of 0 and receipt of prednisolone ≤ 4mg daily and no receipt of oral corticosteroids above baseline during the treatment period. Secondary outcomes will include reduction in disease flare, improvement in scores for asthma control, sino-nasal disease and spirometry amongst others.

Being tested
Tezepelumab, Placebo
Keywords
EGPA, Eosinophilic granulomatosis with polyangiitis, Tezepelumab, Mechanism, Alarmin, Vasculitis, Experimental Medicine
Medical subject headings
Churg-Strauss Syndrome, Vasculitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TezepelumabDrug

    Tezepelumab subcutaneous injection

  • PlaceboDrug

    Placebo subcutaneous injection

Study groups in NCT06230354
Study groupRoleWhat they receive
TezepelumabExperimentalTezepelumab subcutaneous injection
Receives: Drug: Tezepelumab
PlaceboPlacebo comparatorPlacebo subcutaneous injection
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants who are in remission at week 24

    The proportion of patients who achieve remission at week 24 (defined as a Birmingham Vasculitis Activity Score (BVAS) version 3 score of 0 and receipt of prednisolone of ≤ 4mg daily and no receipt of oral steroids above baseline dose in the 4 weeks prior to week 24). BVAS is a validated tool for assessment of disease activity in patients with vasculitis with potential scores ranging from 0-63, with higher scores indicating worse disease activity.

    Measured: Week 24

Secondary outcomes (11)

  1. Time to first EGPA relapse

    EGPA relapse was defined as worsening or recurrence of active disease since the last visit characterised by active vasculitis (BVAS >0) or active asthma symptoms and/or signs with a corresponding worsening in Asthma Control Questionnaire-6 (ACQ-6) score or active nasal and/or sinus disease, with a corresponding worsening in at least one of the sino-nasal symptom questions warranting: (i) rescue use of prednisolone/equivalent systemic steroid for 3 or more days OR an increase in background prednisolone/equivalent systemic steroid dose by at least 5 mg daily of prednisolone equivalents for at least three days OR (ii) an increased dose or addition of immunosuppressive therapy; OR (iii) hospitalization related to EGPA worsening. The number of participants with at least one EGPA relapse during the planned study treatment period are presented.

    Measured: Up to Week 24

  2. Total accrued duration of remission

    Total accrued weeks of remission defined as defined as a Birmingham Vasculitis Activity Score (BVAS) - version 3, score of 0 with mOCS dose of prednisolone/prednisolone ≤ 4mg/day and BVAS of 0.

    Measured: Up to Week 24

  3. Proportion of participants that demonstrate sustained remission

    The proportion of patients that demonstrate sustained remission at both weeks 20 and 24 (defined as a BVAS version 3 score of 0 and receipt of prednisolone of ≤ 4 mg daily and no receipt of oral steroids above baseline dose between weeks 16 and 24)

    Measured: Up to Week 24

  4. Proportion of participants that tapered mOCS by at least 2.5 mg/day

    Proportion of patients that tapered their maintenance oral corticosteroids (mOCS) by at least 2.5 mg/day of prednisolone equivalent during the OCS tapering period, who remained in remission

    Measured: Up to Week 24

  5. Change in SinoNasal Outcome Test-22 (SNOT-22)

    Change from baseline (week 0) to weeks 12 \& 24 in the SinoNasal Outcome Test-22 questionnaire score (SNOT-22). SNOT-22 is a validated assessment of the burden of chronic rhinosinusitis with potential scores ranging from 0-110, with higher scores indicating a worse impact on health-related quality of life.

    Measured: Between Week 0 and/or Week 12 and Week 24

  6. Change in European Quality of Life 5 Dimensions 5 Level (EuroQoL-5D-5L)

    Change from baseline (week 0) to week 24 in the European Quality of Life 5 Dimensions 5 Level (EuroQoL-5D-5L) questionnaire score. The EuroQoL-5D-5L is a validated standardised descriptive measure of health-related quality of life with potential scores ranging from "no problems" to "extreme problems" in all domains. The questionnaire also asks the participant to indicate their overall health that day on a scale of 0-100, with lower scores indicating worse health.

    Measured: Up to Week 24

  7. Change in Juniper 6-item Asthma Control Questionnaire (ACQ-6)

    Change from baseline to week 12 and 24 in Juniper 6-item Asthma Control Questionnaire (ACQ-6) score. The ACQ-6 is a validated assessment of asthma symptom control, with potential scores ranging from 0-6, with higher scores indicating worse asthma symptom control.

    Measured: Between Week 0 and/or Week 12 and Week 24

  8. Change in blood eosinophil level

    Change from baseline (week 0) to week 12 and 24 in blood eosinophil level

    Measured: Between Week 0 and/or Week 12 and Week 24

  9. Change in spirometry

    Change from baseline (week 0) to weeks 12 and 24 in pre-bronchodilator FEV1% predicted and FEV1/FVC ratio.

    Measured: Between Week 0 and/or Week 12 and Week 24

  10. Change in FeNO

    Change from baseline (week 0) to weeks 12 and 24 in Fractional Exhaled Nitric Oxide level (FeNO).

    Measured: Between Week 0 and/or Week 12 and Week 24

  11. Change in eGFR

    Change from baseline (week 0) to weeks 12 and 24 in estimated glomerular filtration rate (eGFR).

    Measured: Between Week 0 and/or Week 12 and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2024
  2. Study start15 May 2024
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06230354
Sponsor's protocol ID
1007564
Other IDs
21HH7284
Acronym
RACEMATE
Status last verified
Apr 2026
First submitted
8 Jan 2024
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: to be kept with trial team

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tezepelumab in people with EGPA - Eosinophilic Granulomatosis With Polyangiitis, run by Imperial College London at 12 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants who are in remission at week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06230354.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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