The purpose of this study is to evaluate the safety and effectiveness of combination therapy
with etanercept and narrow-band (NB) UVB phototherapy for the treatment of psoriasis in a
pilot study. This is a Phase 4 clinical study being conducted under an Amgen Investigational
New Drug Application (IND).
Time to PASI 75 responsesProportion of subjects achieving PASI 90 at Week 12
Improvement in PASI at Week 12
Improvement in body surface area (BSA) involved with psoriasis at Week 12
Improvement in physician global assesssment of psoriasis, including an assessment of the proportion of subjects achieving clear or almost clear status at Week 12
Improvement in patient global assesssment of psoriasis at Week 12
Improvement in Dermatology Life Quality Index (DLQI) at Week 12
Subject incidence of serious adverse events (SAEs) and events of medical interests (EMI) at Week 12
Inclusion Criteria: - Chronic plaque psoriasis eligible for systemic therapy and NB-UVB in
the opinion of the investigator - Psoriasis Activity and Severity Index (PASI) greater
than or equal to 15 and at least 25% of individual plaques must be considered severe -
Patients must have body surface area (BSA) involvement of greater than or equal to 5% -
Before any study-specific procedure, subject must sign and date the appropriate written
informed consent - Negative urine pregnancy test within 7 days before the first dose of
study drug in all women (except those surgically sterile or at least 5 years
postmenopausal) - Sexually active subjects of childbearing potential must agree to use
medically acceptable form of contraception during screening and throughout the study
Exclusion Criteria: - Prior phototherapy - Current or prior treatment with any tumor
necrosis factor (TNF) antagonist, including etanercept, infliximab and adalimumab -
Erythrodermic, pustular or guttate psoriasis - Evidence of skin conditions (e. g., eczema)
other than psoriasis that would interfere with study-related evaluations of psoriasis -
Evidence of active infections such as fevers, chills, sweats, or history of untreated Lyme
disease and active severe infections within 4 weeks before screening visit or between the
screening and baseline visits - History of immune compromised health [e. g., human
immunodeficiency virus (HIV) positive status] - History of any cutaneous malignancy at any
time, including squamous or basal cell carcinomas or melanoma - History of non-cutaneous
cancer within 5 years - Actinic keratosis or atypical moles - History of alcohol or drug
abuse within 12 months of screening visit - Current enrollment in another clinical study
and treatment with another experimental drug or approved therapy for experimental use
within 30 days prior to etanercept administration - Severe comorbidities as outlined in
ENBREL(r) Package Insert: diabetes mellitus requiring insulin, congestive heart failure of
any severity, myocardial infarction (within less than or equal to 52 weeks before
screening), unstable angina pectoris, oxygen-dependent severe pulmonary disease,
tuberculosis or tuberculosis exposure, chronic hepatitis B or hepatitis C, systemic lupus
erythematosus, history of multiple sclerosis or other demyelinating disease, transverse
myelitis, optic neuritis or epilepsy, uncontrolled hypertension (defined as systolic blood
pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg) -
Contraindications according to the ENBREL(r) Package Insert - Evidence of open cutaneous
ulcers - Evidence of photosensitivity disorder (e. g., polymorphous light eruption) -
Nursing mothers, female subjects planning on becoming pregnant or male subjects planning a
pregnancy with their spouse/partner while in the study - Subjects that cannot commit to
all the assessments required by the protocol - Known photosensitivity or known sensitivity
to any of the excipients or products to be administered during dosing - Any disorder that
compromises the ability of the subject to give written informed consent and/or to comply
with study procedures
