Study to Assess the Immunogenicity and Safety of Etanercept Produced in Plaque Psoriasis

This is a multicenter, open-label, single-arm phase 4 study in subjects with PsO who are
etanercept-naïve and who are not receiving methotrexate therapy. The study will consist of a
screening period of up to 30 days, a 24-week treatment period and a 30-day follow-up period
for safety. Etanercept dosing will follow the recommended label dosing for patients with
PsO.

Inclusion Criteria:

- Subject is ≥ 18 years of age at time of screening.

- Subject is a candidate for systemic therapy or phototherapy in the opinion of the
investigator.

- Subject has involved body surface area (BSA) ≥ 10%, static physician global
assessment (sPGA) ≥ 3, and Psoriasis Area and Severity Index (PASI) ≥ 10 at screening
and at baseline.

- Subject is naïve to etanercept.

- Subject is a candidate for treatment with etanercept in the opinion of the
investigator in addition to the caring physician's intent to initiate treatment with
etanercept, as applicable.

- Subject is able to self-inject etanercept or have a designee who can do so.

- Subject has not used methotrexate within 4-weeks from the first dose of etanercept.

- Subject has a negative test for hepatitis B surface antigen, hepatitis B core
antibody and hepatitis C antibody.

- Subject has no known history of active tuberculosis.

- Subject has a negative test for tuberculosis during screening

- Subject, if female and not at least 2 years postmenopausal or history of
hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, has a negative
serum pregnancy test ≤ 4 weeks from starting etanercept and a negative urine
pregnancy test at baseline (day 1).

Exclusion Criteria:

- Subject has active erythrodermic, pustular, guttate psoriasis, or medication induced
psoriasis, or other skin conditions at the time of the screening visit (eg,eczema)
that would interfere with evaluations of the effect of investigational product on
psoriasis.

- Subject has any uncontrolled, clinically significant systemic disease (eg, renal
failure, heart failure, hypertension, pulmonary or liver disease, diabetes, anemia).

- Myocardial infarction or unstable angina pectoris within the last year.

- Major chronic inflammatory disease or connective tissue disease other than psoriasis
and/or psoriatic arthritis.

- Multiple sclerosis or any other demyelinating disease.

- Active malignancy, including evidence of cutaneous basal or squamous cell carcinoma
or melanoma, Merkel cell carcinoma, or history of cancer (other than fully resected
and surgically cured cutaneous basal cell and squamous cell carcinoma) within 5 years
before the first dose of etanercept. If malignancy occurred more than 5 years ago,
documentation of disease-free state since treatment is required.

- Known history of alcoholic hepatitis or immunodeficiency syndromes including Human
Immunodeficiency virus infection.

- Subject has any active infection (including chronic or localized infections) for
which anti-infectives were indicated within 4 weeks prior to first dose of
etanercept.

- Subject has a serious infection, defined as requiring hospitalization or intravenous
(IV) anti-infectives within 8 weeks prior to first dose of etanercept.

- Any condition that, in the opinion of the investigator, might cause this study to be
detrimental to the subject.

- Subject has any condition that could, in the opinion of the investigator, compromise
the subject's ability to give written consent and/or comply with the study
procedures, such as a history of substance abuse or a psychiatric condition.