Ignite Creation Date:
2024-05-06 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03553823
Status:
COMPLETED
Last Update Posted:
2021-10-11
First Post:
2018-05-15
Brief Title:
Comparison of Secukinumab Versus Guselkumab in Clearing Psoriatic Plaques Refractory to Ustekinumab
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A 16-week Randomized Open-label Multicenter Study to Assess the Superiority of Secukinumab Over Guselkumab in the Complete Treatment of Ustekinumab Resistant Psoriatic Plaques
Status:
COMPLETED
Status Verified Date:
2021-10
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:
ARROW
Brief Summary:
The aim of this study was to describe the effect of direct IL-17A inhibition with secukinumab as compared with the selective inhibition of IL-23 with guselkumab p19 subunit blocker in controlling inflammation in psoriatic plaques that remain active despite treatment with the non-selective IL-23 inhibitor ustekinumab blocker of p40 subunit shared by IL-12 and IL 23
Detailed Description:
This was a 16-week randomized open-label parallel-group active-control Phase 2a study comparing secukinumab 300 mg sc versus guselkumab 100 mg sc in subjects with plaque psoriasis who had an inadequate response to ustekinumab Forty subjects will be randomized 11 and treated for 16 weeks In each patient a target active refractory skin plaque TCS 6 is described and biopsied at baseline and at study end The objective of the study was to assess the superiority of secukinumab over guselkumab in achieving clearalmost clear status TCS 0-2 of the target plaques and to describe the molecular mechanisms behind this difference
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-001048-70 | EUDRACT_NUMBER | None | None |