Clinical trial NCT00791765: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Keywords: Scalp
Psoriasis
Plaque Psoriasis
Skin Diseases
Moderate to severe plaque psoriasis
etanercept
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2008-11-17
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* Psoriasis Scalp Severity Index (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 Human Immunodeficiency Virus (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 Purified Protein Derivative (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 within 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, cyclophosphamide, sulfasalazine, anakinra
* Use of Alefacept (Amevive), Efalizumab (Raptiva), Anti-tumor necrosis factor (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/mm\^3, white blood cell count less than 3,500 cells/mm\^3, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) greater than or equal to 1.5 x the upper limit of normal, any other laboratory abnormality which will prevent patient from completing the study or interfere with interpretation of study results
* Patient is pregnant or breast feeding
* Presence of any condition that could compromise the patient's ability to participate in the study, such as a history of substance abuse or psychiatric condition

Primary outcomes:
measure: Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Percentage of Participants With PSSI 75% Response at Week 12
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in PSSI at Week 24 in Participants Switching From Placebo to Etanercept at Week 12
timeFrame: Baseline and Week 24
measure: Patient Satisfaction With Treatment at Week 12
timeFrame: 12 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Bagel J, Lynde C, Tyring S, Kricorian G, Shi Y, Klekotka P. Moderate to severe plaque psoriasis with scalp involvement: a randomized, double-blind, placebo-controlled study of etanercept. J Am Acad Dermatol. 2012 Jul;67(1):86-92. doi: 10.1016/j.jaad.2011.07.034. Epub 2011 Oct 20.
citation: Tyring S, Bagel J, Lynde C, Klekotka P, Thompson EH, Gandra SR, Shi Y, Kricorian G. Patient-reported outcomes in moderate-to-severe plaque psoriasis with scalp involvement: results from a randomized, double-blind, placebo-controlled study of etanercept. J Eur Acad Dermatol Venereol. 2013 Jan;27(1):125-8. doi: 10.1111/j.1468-3083.2011.04394.x. Epub 2011 Dec 21. No abstract available.