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Phase 4 N=124 Randomized Quadruple-blind Treatment

Moderate to Severe Plaque Psoriasis With Scalp Involvement

Psoriasis

Enrolled (actual)
124
Serious AEs
2.5%
Results posted
Nov 2013
Primary outcome: Primary: Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12 — 20.4; 86.8 Percent change — p=<0.0001

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Etanercept (Biological); Placebo (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Amgen
Primary completion
Jan 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12
20.4; 86.8 <0.0001 sig
SECONDARY
Percentage of Participants With PSSI 75% Response at Week 12
11; 86 <0.0001 sig
SECONDARY
Percent Change From Baseline in PSSI at Week 24 in Participants Switching From Placebo to Etanercept at Week 12
79.1 <0.0001 sig
SECONDARY
Patient Satisfaction With Treatment at Week 12
15; 9; 20; 1; 13; 4 <0.0001 sig

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00791765). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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