Ignite Creation Date:
2024-05-06 @ 4:17 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04930094
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2021-06-15
Brief Title:
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo in Combination With Glucocorticoid Taper Regimen in Patients With Giant Cell Arteritis GCA
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Parallel-group Double-blind Placebo-controlled Multicenter Phase III Trial to Investigate the Efficacy and Safety of Secukinumab 300 mg and 150 mg Administered Subcutaneously Versus Placebo in Combination With a Glucocorticoid Taper Regimen in Patients With Giant Cell Arteritis GCA GCAptAIN
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
This is a phase III study of efficacy and safety of secukinumab versus placebo in combination with glucocorticoid taper regimen in patients with giant cell arteritis GCA
Detailed Description:
Randomized parallel-group double-blind placebo-controlled multi-center Phase III study to evaluate the efficacy of secukinumab in combination with a 26-week prednisone taper regimen compared to pllacebo in combination with a 52-week prednisone taper regimen
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 |
|---|---|---|---|
| 2020-004809-31 | EUDRACT_NUMBER | None | None |