Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06230354
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-18
First Post:
2024-01-08
Brief Title:
Explore the Efficacy and Mechanism of Action of Tezepelumab in Eosinophilic Granulomatosis With Polyangiitis
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
A RAndomised Placebo Controlled Trial - to Explore the Efficacy and Mechanism of Action of Tezepelumab in Eosinophilic Granulomatosis With Polyangiitis
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RACEMATE
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 21HH7284 | OTHER | IMPERIAL | None |