Explore the Efficacy and Mechanism of Action of Tezepelumab in Eosinophilic Granulomatosis With P… (NCT06230354) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Explore the Efficacy and Mechanism of Action of Tezepelumab in Eosinophilic Granulomatosis With Polyangiitis
United Kingdom42 participantsStarted 2024-05-15
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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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:
✓. History of relapsing and refractory disease defined as:
✓. 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).
✓. Non severe EGPA according to the American College of Rheumatology 2021 definition.
✓. 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:
Exclusion criteria
✕. 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:
✕. Current active malignancy.
What they're measuring
1
Proportion of participants who are in remission at week 24