Ignite Creation Date:
2024-05-06 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03364309
Status:
COMPLETED
Last Update Posted:
2021-06-25
First Post:
2017-11-09
Brief Title:
A Study of Ixekizumab LY2439821 in Chinese Participants With Moderate-to-Severe Plaque Psoriasis
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Multicenter Study With a Randomized Double-Blind Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period to Evaluate the Efficacy and Safety of LY2439821 in Chinese Patients With Moderate-to-Severe Plaque Psoriasis
Status:
COMPLETED
Status Verified Date:
2021-06-01
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:
The purpose of this study is to determine the efficacy and safety of the study drug ixekizumab in Chinese participants with moderate-to-severe plaque psoriasis
Detailed Description:
Study I1F-MC-RHBH is a phase 3 multicenter randomized double-blind placebo controlled parallel-group study examining the effect of 2 dose regimens of ixekizumab versus placebo in participants with moderate-to-severe plaque psoriasis Ps during an induction dosing period with dosing for 12 weeks and the primary endpoint measured at 12 weeks followed by a randomized 48-week maintenance dosing period During the maintenance dosing period the study will evaluate the maintenance of responseremission as well as relapse or rebound following treatment withdrawal and response to retreatment following relapse
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 |
|---|---|---|---|
| I1F-MC-RHBH | OTHER | Eli Lilly and Company | None |