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Double-blind, Randomized, Placebo-controlled Study of Recombinant Human Tumor Necrosis Factor Receptor (p75) Fusion Protein Etanercept (Enbrel) in Patients With Moderate to Severe Plaque Psoriasis of the Hands and/or Feet

Phase 1/Phase 2
18 Years
70 Years
Not Enrolling

Thank you

Trial Information

Double-blind, Randomized, Placebo-controlled Study of Recombinant Human Tumor Necrosis Factor Receptor (p75) Fusion Protein Etanercept (Enbrel) in Patients With Moderate to Severe Plaque Psoriasis of the Hands and/or Feet

This 24-week multicenter study consists of two phases. The first phase is a 12 week,
double-blind, randomized trial of etanercept, 50 mg twice weekly versus placebo in subjects
with PPP. Subjects who meet the eligibility criteria will be randomized to either 50 mg
etanercept twice weekly or placebo. Subcutaneous injections will occur twice weekly at
approximately the same time of day over the first 12-week treatment period. The primary
efficacy endpoint will be assessed after 12 weeks of treatment. At the end of the first 12
weeks, all patient (both treatment and placebo arms) will be treated with etanercept 50 mg
twice a week (BIW) for an additional 12 weeks.

Inclusion Criteria:

- Moderate to severe palmar plantar psoriasis based on physician's global assessment

- Between 18 and 70 years of age

- Negative urine pregnancy test at screening and at baseline

- Sexually active men and women of child-bearing potential must agree to use a
medically accepted form of contraception (birth control) during the exclusionary
medicine wash-out period and throughout the study.

- Ability to self inject study drug or have a designee who can do so

- Capable of understanding and giving written voluntary informed consent

Exclusion Criteria:

- Previous treatment with Enbrel® (etanercept) or similar drugs

- Receipt of investigational drugs or "biologics" within 4 weeks of the screening

- Evidence of skin conditions (e.g. eczema) other than psoriasis that would interfere
with evaluations of the study medication.

- Receipt of any biologic medication within the previous 6 months that resulted in a
decreased white blood cell count (cells to help fight infections)

- Ultraviolet light treatment (e.g. UVB, PUVA) within one month prior to study drug

- Receipt of immune-suppressing drugs other than Rheumatrex® (methotrexate) or
Soriatane® (acetretin) within 4 weeks prior to the first dose of study drug.
Medications you would not be allowed to take during this study include for example,
Cytoxan® (cyclosporine), Imuran® (azathioprine), or Sulfazine® (sulfasalazine). If
you remain on Rheumatrex® (methotrexate) (≤25 mg/week) or Soriatane® (acitretin) (≤50
mg/day), you must be considered to have inadequate disease control in the opinion of
the investigator based on physician's global assessment. You must have been on a
stable dose of systemic treatment for at least 1 month prior to the start of the
study medication. You will be required to maintain a stable dose of the systemic
treatment throughout the study.

- Use of topical steroids in the past 14 days unless they have been used for longer
than 14 days and the severity of disease allows entry into study.

- Systemic steroid use (prednisone, etc).

- Prior or concurrent use of Cytoxan® (cyclophosphamide).

- Elevated liver tests; red blood cell count less than normal; decreased platelet count
(cells to help with blood clotting); decreased white blood cell count (cells to fight
infection); kidney insufficiency

- Any severe adverse event, infection or abnormal laboratory value at the time of the
screening visit that would preclude participation in the study

- Presence of a severe infection, less than 30 days prior to the screening visit or
between the screening visit and the first dose of study drug

- Pregnant or breast-feeding females.

- Significant concurrent medical diseases including: Uncompensated congestive heart
failure (heart is unable to pump as normal): Myocardial infarction (heart attack)
within 12 months of screening period; Unstable or stable angina pectoris (chest pains
related to your heart); Uncontrolled high blood pressure

- Severe lung disease requiring medical or oxygen therapy

- History of cancer (other than surgically removed skin cancer and in situ cervical
cancer) within 5 years of the screening visit

- History of tuberculosis

- Known to be HIV positive

- Rheumatoid arthritis

- Any neurologic demyelinating disease (such as multiple sclerosis or any neurologic
disease causing loss of sensation or loss of normal movement) or seizure disorder

- Current or history of psychiatric disease that would interfere with ability to comply
with the study protocol or give informed consent.

- History of alcohol or drug abuse.

- Not up-to-date with all immunizations in agreement with the current immunization

- Significant exposure to the varicella virus (chicken pox)

- Guttate or generalized pustular psoriasis

- Surgery or trauma within a month of baseline considered by the investigator to
represent a significant risk or interfere with patient evaluation.

Type of Study:


Study Design:

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

Outcome Measure:

The Number of Subjects Who Achieve a 50% Reduction in the Palmoplantar Psoriasis Severity Index at 12 Weeks

Outcome Description:

Psoriasis area and severity index (PASI) is the most widely used tool for the measurement of severity of psoriasis. This tool is used to assess the skin lesions of the entire body however, the palmoplantar psoriasis severity index is a modified form of the the PASI that is assessed for skin lesions of the hands and feet only. The severity is estimated by three clinical signs: erythema induration and desquamation. Severity parameters are measured on a scale of 0 to 4.. The sum of all three severity parameters is then calculated based on surface area affected.

Outcome Time Frame:

Week 12

Safety Issue:


Principal Investigator

Gerald D Weinstein, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Irvine


United States: Food and Drug Administration

Study ID:




Start Date:

May 2007

Completion Date:

May 2008

Related Keywords:

  • Psoriasis
  • palmoplantar psoriasis
  • etanercept
  • Enbrel
  • Psoriasis



Wake Forest University School of Medicine Winston-Salem, North Carolina  27157-1023
Dermatology Associates, PLLC Seattle, Washington  98101
UC Irvine Dermatology Clinical Research Center Irvine, California  92697