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Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis

Last updated on February 23, 2019

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Study Location
Pfizer Investigational Site
Little Rock, Arkansas, 72202 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis, Immunomodulation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male and/or female subjects between the ages of 18 and 65 years, inclusive, with
active psoriasis lesion(s).

- Subjects should be healthy with the exception of psoriasis, where healthy is defined
as no clinically relevant abnormalities identified by a detailed medical history, full
physical examination. Blood pressure must be 18-36 kg/m2, inclusive; and a total body weight >50 kg (110 lbs)

- The following laboratory variables must be no more than 10% below the lower limit of
the normal reference range: RBC, hemoglobin, hematocrit, WBC, absolute neutrophil
count. The absolute lymphocyte count must be greater than or equal to the lower limit
of the reference range. Values for AST, ALT, bilirubin and alkaline phosphatase must
be no more than 10% above the upper limit of the normal reference range. Values for
total cholesterol and LDL must be no more than 20% above the upper limit of the normal
reference range except for subjects being treated for hyperlipidemia. Normal
glomerular filtration rate (> 80 mL/min).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects with evidence or history of clinically significant hematological, renal,
urological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic,
psychiatric, neurologic disorder.

- Subjects with controlled essential hypertension and/or hyperlipidemia may be eligible
for the study provided that any medications that are administered.

- Screening 12-lead ECG demonstrating at least one of the following: heart rate > 100
bpm, QRS >120 msec, QTc > 430 msec (males), QTc > 450 msec (females) or PR > 220 msec.

- Abnormal chest radiographs including, but not limited to, evidence of past or present
tuberculosis infection. History of tuberculosis without treatment and/or positive
tuberculin reaction without known vaccination with BCG.

- Subjects with a history of tumors with the exception of adequately treated basal cell
carcinoma of the skin.

NCT01736696
Pfizer
Completed
Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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