Moderate to Severe Plaque Psoriasis With Scalp Involvement

Original Study ID : 20080014

NCT ID : NCT00791765

Brief Title : Moderate to Severe Plaque Psoriasis With Scalp Involvement

Official Title : A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Treating Scalp Involvement in Subjects With Moderate to Severe Plaque Psoriasis

Brief Summary :

The purpose of this study is to determine if etanercept is effective in the treatment of scalp involvement in moderate to severe plaque psoriasis.

Source : Amgen

Overall Status : Recruiting

Start Date : October 2008

End Date : June 2010

Completion Date : June 2010

Official Title : Phase 4

Phase : Interventional

Study Design : Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Enrollment : 120

Verification Date : April 2009

First Received Date : November 14, 2008

Trial Eligibility

Criteria :
Inclusion Criteria:

- Must provide written informed consent before any study-specific procedure

- Be male or female greater than or equal to 18 years of age at time of screening

- Has stable moderate to severe plaque psoriasis for at least 6 months

- Affected body surface area (BSA) greater than or equal to 10%

- Psoriasis Area and Severity Index (PASI) score greater than or equal to 10

- At least 30 percent affected scalp surface area

- PSSI score greater than or equal to 15

- Candidate for systemic therapy or phototherapy in the opinion of the investigator

- Negative test for hepatitis B surface antigen, hepatitis C antibody, and HIV

- Negative serum pregnancy test for female subjects (unless 3 years post menopausal or
surgically sterile)

- Willing to use medically acceptable form of birth control for duration of study

- Negative PPD within 30 days prior to first dose of study drug

Exclusion Criteria:

- Any active infection

- Significant concurrent medical conditions, including: Insulin dependent diabetes
mellitus; Congestive heart failure; Myocardial infarction within last year; Unstable
angina pectoris; Uncontrolled hypertension; Severe pulmonary disease [requiring oxygen
therapy or hospitalization]; Systemic lupus erythematosus; Multiple sclerosis or any
other demyelinating disease; Active malignancy

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

- History of cancer wthing 5 years before first dose of study drug

- Skin conditions other than psoriasis that would interfere with evaluations of the
effect of study medications on psoriasis

- Presence of guttate, erythrodermic or pustular psoriasis

- Use of topical cyclosporine or calcineurin inhibitors within 14 days of first dose of
study drug

- Use of tar shampoos within 14 days of first dose of study drug

- Use of following therapies within 28 days of first dose of study drug: IV or oral
cyclosporine or calcineurin inhibitors, Ultraviolet Light A therapy, Psoralen plus
ultraviolet A radiation, Oral retinoids, Ultraviolet Light B therapy, Topical steroids
or steroid shampoo, Topical vitamin A or D analog preparations, Anthralin, other
systemic psoriasis therapy, cyclophsphamide, sulfasalazine, anakinra

- Use of Alefacept (Amevive), Efalizumab (Raptiva), Anti-TNF biologic therapies within 3
months of the first dose of study drug. Prior anti-TNF use will not be permitted if
discontinued due to lack of efficacy, an adverse event, or non-compliance.

- Use of interleukin (IL)-12/IL-23 within 6 months of the first dose of study drug

- Participation in another clinical trial within 90 days or 5 half-lives (whichever is
longer) of randomization

- Laboratory abnormalities at screening: hemoglobin less than 11 g/dL, platelet count
less than 125,000/mm3, white blood cell count less than 3,500 cells/mm3, AST/ALT
greater than or equal to 1.5 x the upper limit of normal, any other laboratory
abnormality which will prevent subject from completing the study or interfere with
interpretation of study results

- Subject is pregnant or breast feeding

- Presence of any condition that could compromise the subject's ability to participate
in the study, ex: history of substance abuse or psychiatric condition

Gender : Both

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities