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A Randomized, Double-Blind, Placebo-Controlled, Phase IIa Study of the Clinical Activity, Safety, and Tolerability of SRT2104 in Subjects With Moderate to Severe Plaque-Type Psoriasis
This double-blind, placebo-controlled study will be conducted at 5 study centers in the United States. Approximately 30 subjects with moderate to severe plaque-type psoriasis will take part. The study will consist of a screening period of up to 21 days, a 12-week treatment period with 7 on-treatment clinic visits (approximately one every 2 weeks) and a post-dosing follow-up clinic visit approximately 30 days after the last dose of study drug is taken. Subjects will be randomized to receive either 250mg, 500mg or 1000mg of study drug or placebo. Study drug will be taken by mouth on a full stomach, every day for 84 days. Vital signs, clinical laboratory results (hematology, chemistry, and urinalysis), ECGs and physical examinations will be assessed at periodic intervals from Day 1 through Day 84. A skin biopsy will be taken at the beginning and the end of the dosing period to evaluate any effects of the study drug on psoriasis. Investigators will perform other psoriasis evaluations (including the Psoriasis Area and Severity Index \[PASI\] and the Physician's Global Assessment \[PGA\] at 5 different times throughout the study to quantify the effects of SRT2104 on psoriasis activity. Subjects will complete questionnaires throughout the study, to document their sense of well-being and mood at 4 different times during the study. Five blood samples will be obtained at different timepoints during the study, to measure the amount of SRT2104 in the body.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Portland, Oregon, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Johnston, Rhode Island, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Seattle, Washington, United States
Start Date
June 7, 2010
Primary Completion Date
November 9, 2011
Completion Date
November 9, 2011
Last Updated
October 13, 2017
40
ACTUAL participants
Placebo
DRUG
SRT2104
DRUG
Lead Sponsor
Sirtris, a GSK Company
Collaborators
NCT07449234
NCT07116967
NCT07250802
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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