Study of the Clinical Activity, Safety, and Tolerability of SRT2104 in Subjects With Moderate to Severe Plaque-Type Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 80
Updated:10/15/2017
Start Date:June 7, 2010
End Date:November 9, 2011

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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.


Inclusion Criteria:

- Able and willing to provide written informed consent to participate in the study

- Be male or female aged 18 to 80 years (inclusive)

- Have a diagnosis of clinically confirmed, stable (without recent documented flare
within 30 days prior to the Screening Visit), plaque-type psoriasis for at least 6
months involving ≥10% of body surface area

- Have a baseline PASI of ≥10

- Be a candidate for systemic psoriasis therapy, in the opinion of the investigator

- If a female subject of child-bearing potential, be willing to use reliable
contraception for the duration of the study, through the 30 day safety follow up
telephone call

- Be willing and able to comply with the protocol for the duration of the study

Exclusion Criteria:

- Has received systemic non-biologic psoriasis therapy or PUVA phototherapy within 4
weeks prior to the Screening Visit, or had topical psoriasis treatment or UVB
phototherapy within 2 weeks prior to the Screening Visit

- Has received previous treatment with biologic agents within 5 drug half-lives (or
within 3 months if half-life is unknown) prior to the first dose of SRT2104

- Has received a live vaccination within 4 weeks prior to the Screening Visit or intends
to have a live vaccination during the course of the study

- Use of any other non-psoriatic prescription drug therapy, with the exception of any
prescription medication administered at a stable dose for at least 6 weeks prior to
the Screening Visit; however, the administration of proton pump inhibitors during the
study dosing period is prohibited

- Use of any dietary or herbal supplements, with the exception of those administered at
a stable dose for at least 6 weeks prior to the Screening Visit

- Has received any investigational drug or experimental procedure within 30 days prior
to the first dose of SRT2104

- Has an active infection (e.g., sepsis, pneumonia, abscess, etc.) or be at high risk of
developing an infection, in the opinion of the investigator, prior to the first dose
of SRT2104

- Has a history of a positive tuberculosis test or a positive tuberculosis test at the
Screening Visit that cannot be attributed to a prior BCG inoculation

- Has a positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
result within 3 months of the Screening Visit

- Has a positive test for HIV antibody

- Has an abnormal chest x-ray at the Screening Visit which, in the opinion of the
investigator, would preclude entry into the trial

- Has a 12-lead electrocardiogram (ECG) with changes considered to be clinically
significant on medical review including prolonged QTc intervals as defined below:

- QTcB ≥450 msec (based on single or average QTc value of triplicate ECGs obtained over
a brief period)

- QTcB ≥480 msec in subjects with Bundle Branch Block

- Has renal or liver impairment, defined as:

- Serum creatinine level of ≥ 1.4 mg/dL for females and ≥ 1.5 mg/dL for males

- AST and ALT ≥ 2xULN or

- Alkaline phosphatase and bilirubin > 1.5xULN (an isolated bilirubin >1.5xULN is
acceptable if bilirubin is fractionated and direct bilirubin is <35%)

- Has active neoplastic disease or history of neoplastic disease within 5 years of study
entry (except for basal or squamous cell carcinoma of the skin, or carcinoma in situ
which have been definitively treated with standard of care approaches)

- Is pregnant or breast-feeding. Confirmation that a female subject is not pregnant must
be established by negative pregnancy tests at Screening and Day 1

- Has a significant history of alcoholism or drug/chemical abuse, or consumes more than
3 standard units/day of alcohol. A standard unit of alcohol is defined as 250 mL of
beer, 25 mL of spirit, or 125 mL of wine

- History of sensitivity to any of the study medications, or components thereof, or a
history of drug or other allergy that, in the opinion of the investigator or medical
monitor, contraindicates their participation

- Has an acute or chronic illness which, in the opinion of the investigator, could pose
a threat or harm to the subject
We found this trial at
7
sites
New York, New York 10032
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Dallas, Texas 75230
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Dallas, TX
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Johnston, Rhode Island 02919
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Johnston, RI
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Portland, Oregon 97227
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Portland, OR
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Saint Louis, Missouri 63110
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Saint Louis, MO
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Seattle, Washington 98109
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Seattle, WA
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