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COMPLETEDPHASE4

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

NCT00791765•Amgen

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)
+2 more criteria

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.
+5 more criteria

Key Dates

Start Date

October 1, 2008

Primary Completion Date

January 1, 2010

Completion Date

March 1, 2010

Last Updated

July 23, 2014

Enrollment

124

ACTUAL participants

Conditions

Psoriasis

Interventions

Etanercept

BIOLOGICAL

Placebo

BIOLOGICAL

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Moderate to Severe Plaque Psoriasis With Scalp Involvement

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments