Ignite Creation Date:
2024-05-06 @ 1:21 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01782664
Status:
COMPLETED
Last Update Posted:
2017-08-03
First Post:
2013-01-31
Brief Title:
A Dose Ranging Study to Evaluate the Safety and Efficacy of GSK2586184 in Patients With Chronic Plaque Psoriasis
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Multi-centre Randomised Double-blind Placebo-controlled Dose Ranging Study to Evaluate the Safety and Efficacy of GSK2586184 in Patients With Chronic Plaque Psoriasis
Status:
COMPLETED
Status Verified Date:
2017-01
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:
A multi-centre randomised dose ranging study to evaluate the safety and clinical efficacy of GSK2586184 in patients with chronic plaque psoriasis
There will be 2 study cohorts Cohorts A and B Cohort A is the main study cohort and this part of the study will be randomised double-blind and placebo-controlled Fifty-six subjects will be randomised in Cohort A 14 subjects in each treatment group 100 mg 200 mg or 400 mg GSK2586184 or placebo Cohort B is an exploratory open-label investigation of the effect of 400 mg GSK2586184 on inflammatory gene expression in the skin and whole blood and GSK2586184 concentrations in the skin A maximum of 8 subjects will be included and all subjects will take 400 mg GSK2586184
In both Cohorts A and B study medication will be administered orally as tablets twice daily for up to 12 weeks
Each subject will have 7 out-patient visits Screening Baseline Start of treatment Week 2 Week 4 Week 8 Week 12 and Follow-up Week 16
There will be 2 study cohorts Cohorts A and B Cohort A is the main study cohort and this part of the study will be randomised double-blind and placebo-controlled Fifty-six subjects will be randomised in Cohort A 14 subjects in each treatment group 100 mg 200 mg or 400 mg GSK2586184 or placebo Cohort B is an exploratory open-label investigation of the effect of 400 mg GSK2586184 on inflammatory gene expression in the skin and whole blood and GSK2586184 concentrations in the skin A maximum of 8 subjects will be included and all subjects will take 400 mg GSK2586184
In both Cohorts A and B study medication will be administered orally as tablets twice daily for up to 12 weeks
Each subject will have 7 out-patient visits Screening Baseline Start of treatment Week 2 Week 4 Week 8 Week 12 and Follow-up Week 16
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