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NCT01154101 · ClinicalTrials.gov registry record · Phase 2
Study of the Clinical Activity, Safety, and Tolerability of SRT2104 in Subjects With Moderate to Severe Plaque-Type Psoriasis
A Phase 2 study of Psoriasis, sponsored by Sirtris, a GSK Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 8
- Study locations
NCT01154101 is a Phase 2 study of Psoriasis that has completed, run by Sirtris, a GSK Company. The registered enrollment target is 40 participants, below the 488-participant average among 125 other Psoriasis trials with a reported enrollment target (92% lower). The trial reports 8 study locations across 7 states.
The verdict
NCT01154101, a Phase 2 study of Psoriasis, has completed, sponsored by Sirtris, a GSK Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 8
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SRT2104
Study Locations (8)
New York
- GSK Investigational Site - New York
- GSK Investigational Site - New York
Missouri
- GSK Investigational Site - St Louis
Oregon
- GSK Investigational Site - Portland
Pennsylvania
- GSK Investigational Site - Philadelphia
Rhode Island
- GSK Investigational Site - Johnston
Texas
- GSK Investigational Site - Dallas
Washington
- GSK Investigational Site - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2010-06-07 |
| Est. Completion | 2011-11-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01154101
The ClinicalTrials.gov registry entry for NCT01154101 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 488-participant average among 125 other Psoriasis trials with a reported enrollment target (92% lower). The listed sponsor is Sirtris, a GSK Company, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Psoriasis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01154101 reports 8 study locations spanning 7 distinct geographic areas - top geographies include New York, Missouri, Oregon.
Frequently Asked Questions
What is clinical trial NCT01154101 about?
NCT01154101 is a clinical study titled "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...
What is the current status of trial NCT01154101?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2010-06-07. Estimated completion is 2011-11-09.
What conditions does trial NCT01154101 study?
This clinical trial studies the following conditions: Psoriasis.
What interventions are being tested in trial NCT01154101?
The interventions under investigation include: Placebo (DRUG), SRT2104 (DRUG).
Who is sponsoring clinical trial NCT01154101?
This trial is sponsored by Sirtris, a GSK Company, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01154101 being conducted?
This trial has 8 study locations across Missouri, New York, Oregon, Pennsylvania, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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