Ignite Creation Date:
2024-05-05 @ 11:12 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01276847
Status:
COMPLETED
Last Update Posted:
2015-01-26
First Post:
2011-01-12
Brief Title:
A Study to Assess the Effect of Ustekinumab Stelara and Etanercept Enbrel in Participants With Moderate to Severe Psoriasis MK-0000-206
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Clinical Trial to Assess the Effects of Ustekinumab and Etanercept on Skin and Blood Biomarkers of Psoriasis in Patients With Moderate to Severe Disease
Status:
COMPLETED
Status Verified Date:
2015-01
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:
This is a two-part study The purpose of the pilot study Part 1 is to optimize the acquisition handling and shipping procedure for skin biopsies obtained from participants with plaque psoriasis No treatment will be administered Part 2 will include 2 cohorts In Cohort 1 the effects of 16 weeks of treatment with either ustekinumab or etanercept on biomarkers in lesional skin in participants with moderate to severe psoriasis will be evaluated In Cohort 2 biomarkers of lesional skin from participants with moderate to severe psoriasis who are not treated with biologic therapy will be evaluated over 16 weeks The primary hypothesis is that treatment with ustekinumab reduces messenger RNA mRNA expression of genes in the interleukin 12 IL-12 pathway that are modulated by interferon gamma IFN-γ
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