Moderate to Severe Plaque Psoriasis With Scalp Involvement

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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Biological: Etanercept; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo BIW/Etanercept 50 mg BIW; Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.	Biological: Etanercept; Etanercept for subcutaneous injection.; Other Names: Enbrel®; Biological: Placebo; Placebo for subcutaneous injection.
Experimental: Etanercept 50 mg BIW/Etanercept 50 mg QW; Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.	Biological: Etanercept; Etanercept for subcutaneous injection.; Other Names: Enbrel®; Biological: Placebo; Placebo for subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12	The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area.	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With PSSI 75% Response at Week 12	Percentage of participants achieving at least a 75% improvement from baseline in the Psoriasis Scalp Severity Index (PSSI) at Week 12. The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area. PSSI 75 indicates at least a 75% improvement in the PSSI score from baseline.	Baseline and Week 12
Percent Change From Baseline in PSSI at Week 24 in Participants Switching From Placebo to Etanercept at Week 12	Percent change from baseline in Psoriasis Scalp Severity Index (PSSI) in participants switching from placebo to etanercept at Week 12 (Group B) at Week 24. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicate more severe disease. The PSSI calculation does not include the face or neck area.	Baseline and Week 24
Patient Satisfaction With Treatment at Week 12	This response scale was adapted from the Medical Outcomes Study: Patient Satisfaction Survey. To assess satisfaction with treatment, the participant was asked to check a box (from "very dissatisfied" to "very satisfied") to indicate his or her level of satisfaction with the medication's control of psoriasis.	12 Weeks

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: November 14, 2008
• First Submitted That Met QC Criteria: November 14, 2008
• First Posted (Estimate): November 17, 2008

Study Record Updates

• Last Update Posted (Estimate): July 23, 2014
• Last Update Submitted That Met QC Criteria: July 14, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Psoriasis; Plaque Psoriasis; Scalp; Skin Diseases; etanercept; Moderate to severe plaque psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: 20080014