Moderate to Severe Plaque Psoriasis With Scalp Involvement

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791765
• Other study ID #: 20080014
• Status: Completed
• Phase: Phase 4
• First received: November 14, 2008
• Last updated: July 14, 2014
• Start date: October 2008
• Est. completion date: March 2010

Study information

• Verified date: July 2014
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review BoardUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: March 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• Etanercept
Etanercept for subcutaneous injection.
• Placebo
Placebo for subcutaneous injection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   AmgenTrials clinical trials website