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

NCT06230354 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 100756421HH7284
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 12

Brief 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).

Conditions

EGPA - Eosinophilic Granulomatosis With Polyangiitis

Keywords

EGPA; Eosinophilic granulomatosis with polyangiitis; Tezepelumab; Mechanism; Alarmin; Vasculitis; Experimental Medicine

Outcome Measures

Primary Outcomes (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.

  Week 24

Secondary Outcomes (11)

• Time to first EGPA relapse

  Up to Week 24

• Total accrued duration of remission

  Up to Week 24

• Proportion of participants that demonstrate sustained remission

  Up to Week 24

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

  Up to Week 24

• Change in SinoNasal Outcome Test-22 (SNOT-22)

  Between Week 0 and/or Week 12 and Week 24

Other Outcomes (4)

• Change in uACR

  Between Week 0 and/or Week 12 and Week 24

• Change in ANCA

  Between Week 0 and/or Week 12 and Week 24

• EGPA relapse type

  Up to Week 24

Study Arms (2)

Tezepelumab

EXPERIMENTAL

Tezepelumab subcutaneous injection

Drug: Tezepelumab

Placebo

PLACEBO COMPARATOR

Placebo subcutaneous injection

Drug: Placebo

Interventions

Tezepelumab DRUG

Tezepelumab subcutaneous injection

Tezepelumab

Placebo DRUG

Placebo subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify 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.

Sponsors & Collaborators

• Imperial College London: lead
• AstraZeneca: collaborator

Study Sites (12)

Aberdeen Royal Infirmary - NHS Grampian

Aberdeen, AB25 2ZN, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2GW, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Royal Infirmary of Edinburgh - NHS Lothian

Edinburgh, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Location

University Hospitals of Leicester NHS Trust

Leicester, LE3 9QP, United Kingdom

Location

Liverpool University Hospitals NHS Foundation Trust

Liverpool, L7 8YE, United Kingdom

Location

Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

Location

Royal Free London NHS Trust

London, NW3 2QG, United Kingdom

Location

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

London, SE1 9RT, United Kingdom

Location

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

London, SW3 6NP, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W2 1PG, United Kingdom

Location

MeSH Terms

Conditions

Churg-Strauss Syndrome; Vasculitis

Interventions

tezepelumab

Condition Hierarchy (Ancestors)

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vascular Diseases; Cardiovascular Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Salman Siddiqui, MBBS

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 30, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (12)