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(JKR-0716) SRT2104 in Subjects with Moderate to Severe Plaque-Type Psoriasis

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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

Principal Investigator:
James G. Krueger M.D., Ph.D.

Mary Sullivan-Whalen N.P.
Kristine Nograles MD
Michelle Lowes MD, PhD
Patricia Gilleaudeau N.P.

Contact Information:
Clinical Research Support Office
The Rockefeller University
1230 York Avenue
New York, NY 10065
Telephone: 1.800.RUCARES
Alt. Telephone: 1.800.782.2737
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
Psoriasis is a chronic, non-infectious disease that affects mainly the skin. The actual cause of psoriasis is not known. One possible cause may be due to an altered inflammation response. Inflammation is a normal bodily response to fight infections and heal injuries. Changes in the body‟s inflammation system may cause conditions like psoriasis. Drugs that help to regulate inflammation are called anti-inflammatory drugs. SRT2104 has been tested in animals and found to have anti-inflammatory effects. The purpose of this research study is to: test the safety and tolerability of 3 doses of the study drug, SRT2104 compared to placebo (inactive substance with no active drug) in subjects with psoriasis; see how SRT2104 is absorbed and removed from the body and how SRT2104 affects the body; and determine whether SRT2104 has any effect on the skin when taken for 12 weeks.

Detailed Description of Protocol:
About 30 subjects will take part in the research study. If you join the research study, your participation will last about 18 weeks and will include at least 9 visits to the study site. You may have to return to the study site between study visits. In this study, some subjects will take SRT2104 pills and some will take a placebo pill. Because this is a research study, the “study drug” (that is, either SRT2104 or placebo) will be given to you only during this study and not after the study is over.

What specifically makes a person eligible for the study?
You may be eligible to enter this study:

- Ages 18-80
- Confirmed diagnosis of Plaque-type Psoriasis
- Psoriasis is covering at least 10% of your body
- Have not had a flare up in the past month



Children permitted to participate:

Potential Benefits.....
You may benefit as a result of your participation in this study. There is, however, no guarantee that you will benefit from your participation in this study. Results from this study may benefit others in the future.

Compensation is provided.