NCT06230354

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

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

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

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 16 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.

Conditions

• EGPA - Eosinophilic Granulomatosis With Polyangiitis

Interventions

Type	Name	Description
DRUG	Tezepelumab	Tezepelumab subcutaneous injection
DRUG	Placebo	Placebo subcutaneous injection

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2024-01-30
• Last updated: 2024-04-18

Locations

13 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study