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Study Evaluating Single Dose Of ILV-095 In Psoriasis Subjects

Last updated on March 14, 2019

Study Location
Pfizer Investigational Site
Miami Gardens, Florida, 33169 United States
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Plaque Psoriasis
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Sexually active men or women must agree to use a medically acceptable form of
contraception during the study and continue it for 16 weeks after investigational
product administration.

- Negative urine pregnancy test result for all women.

- Body mass index (BMI) >=18 kg/m2 and body weight >=50 kg. BMI is calculated by taking
the subject's weight, in kilograms, divided by the square of the subject's height, in
meters, at screening: BMI = weight (kg)/(height [m]).

- Must meet the following criteria for disease activity, at screening and/or at study
entry (subjects who washout from prior therapy may not meet this level of disease
activity at screening but must before being entered into the study).

- Must have stable moderate to severe chronic plaque psoriasis covering >=15% of body
surface area and be a candidate for systemic therapy or phototherapy.

- Psoriasis Area Severity Index (PASI) score of >11.

- Physician Global Assessment (PGA) of psoriasis score >=3.

- Target lesion score >=6 based on the physician rating of selected sites for erythema,
plaque elevation and scaling, with a minimum of 2 on the plaque elevation score.
A-12-point score will be used with a 1-4 scale for each domain. Target lesions should
not be on the scalp, axillae, face, or groin.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Presence or history of any disorder that may prevent the successful completion of the

- Evidence of unstable clinically significant disease (eg, unstable cardiovascular,
renal, respiratory, or psychiatric disease or any serious disorder that currently
requires physician care).

- Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before
study day 1.

- Evidence of skin conditions (eg, eczema) other than psoriasis that would interfere
with evaluations of the effect of study medication on psoriasis.

- Presence of guttate, erythrodermic, or pustular psoriasis.

- Active severe infections within 4 weeks before study day 1.

- Systemic malignancy within the past 5 years including melanoma. Treated skin cancer
(basal cell carcinoma or squamous cell carcinoma) is excluded.

Evidence of latent tuberculosis by purified protein derivative (PPD) screening. PPD
screening should be performed according to local standards using the tuberculin skin test
(TST). Any result >5mm is considered positive. Prior Bacillus Calmette-Guerin (BCG) should
not be taken into account when interpreting a TST result. TST must be performed during the
screening period unless one has been performed within the previous 3 months and the results
are available.

Study Evaluating Single Dose Of ILV-095 In Psoriasis Subjects


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