Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT01199302
Status:
TERMINATED
Last Update Posted:
2021-12-28
First Post:
2010-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Long-term Safety Study of Brodalumab in Adults With Crohn's Disease
Sponsor:
Amgen
Organization:
Study Overview
Official Title:
A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease
Status:
TERMINATED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated early based on an imbalance in worsening Crohn's disease in active treatment groups.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of long-term treatment with brodalumab in adults with Crohn's disease.
Detailed Description:
This study is an open-label extension of study 20090072 (NCT01150890) in adults with Crohn's disease.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2010-020881-53 | EUDRACT_NUMBER | None | View |