Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04612790
Status:
TERMINATED
Last Update Posted:
2023-11-18
First Post:
2020-10-12
Brief Title:
A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Multinational Randomized Double-blind Parallel-group Placebo-controlled Study to Investigate the Use of Benralizumab as a Treatment Option for Patients With Bullous Pemphigoid FJORD
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Independent Data Monitoring Committee recommended terminating the study following a pre-planned analysis as the efficacy results did not meet the pre-defined futility guidelines There were no new safety concerns identified from this analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FJORD
Brief Summary:
The purpose of this study is to investigate the use of benralizumab is effective in the treatment of patients symptomatic Bullous Pemphigoid BP
Detailed Description:
Bullous pemphigoid BP is a rare disease mainly affecting the elderly BP is associated with significant morbidity and increased mortality secondary to increased risk of secondary infections comorbid conditions and serious side effects from high-dose steroids and immunosuppressants The aim of this study is to investigate the use of benralizumab as a treatment for patients symptomatic with Bullous Pemphigoid BP
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-505033-27-00 | OTHER | None | None |
| 2020-000287-32 | EUDRACT_NUMBER | EU CT | None |