Moderate to Severe Plaque Psoriasis With Scalp Involvement

NCT00791765 | Completed Phase 4 Results

• 1 other identifier: 20080014
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriasis

Keywords

Scalp; Psoriasis; Plaque Psoriasis; Skin Diseases; Moderate to severe plaque psoriasis; etanercept

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of Participants With PSSI 75% Response at Week 12

  Baseline and Week 12

• Percent Change From Baseline in PSSI at Week 24 in Participants Switching From Placebo to Etanercept at Week 12

  Baseline and Week 24

• Patient Satisfaction With Treatment at Week 12

  12 Weeks

Study Arms (2)

Placebo BIW/Etanercept 50 mg BIW

EXPERIMENTAL

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; Biological: Placebo

Etanercept 50 mg BIW/Etanercept 50 mg QW

EXPERIMENTAL

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; Biological: Placebo

Interventions

Etanercept BIOLOGICAL

Etanercept for subcutaneous injection.

Also known as: Enbrel®

Etanercept 50 mg BIW/Etanercept 50 mg QW; Placebo BIW/Etanercept 50 mg BIW

Placebo BIOLOGICAL

Placebo for subcutaneous injection.

Etanercept 50 mg BIW/Etanercept 50 mg QW; Placebo BIW/Etanercept 50 mg BIW

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related 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.

  PMID: 22014541 BACKGROUND

• 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.

  PMID: 22188302 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Psoriasis; Skin Diseases

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2008
• First Posted: November 17, 2008
• Study Start: October 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2010
• Last Updated: July 23, 2014
• Results First Posted: November 7, 2013

Record last verified: 2014-07