Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090129
Status:
TERMINATED
Last Update Posted:
2013-10-22
First Post:
2004-08-24
Brief Title:
Onercept in the Treatment and Re-Treatment of Subjects With Moderate to Severe Plaque Psoriasis
Sponsor:
EMD Serono
Organization:
EMD Serono
Study Overview
Official Title:
A Multicentre Randomised Double-blind Placebo Controlled Phase III Study of Subcutaneously Administered Onercept in the Treatment and Re-treatment of Subjects With Moderate to Severe Plaque Psoriasis
Status:
TERMINATED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The risk-benefit ratio for the use of onercept in this condition was not sufficiently favorable to justify continued development
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The is a double-blind placebo-controlled randomized and multicenter study consisting of a first treatment FT period followed by either an observation OB period and a re-treatment RT period or an open-label OL treatment period depending on FT period response and a 4-week safety follow-up FU period The purpose of this study is to evaluate the safety and efficacy of onercept to be administered as 150 milligram mg three times a week compared to matching placebo for the induction of remission in subjects with moderate to severe plaque psoriasis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None