Study of Tumor Necrosis Factor Receptor Fusion Protein Etanercept (Enbrel) in Psoriasis of the Hands and/or Feet

NCT00585650 | Completed Phase 1 Results DMC

• 2 other identifiers: 20065092Amgen Protocol 20060514
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this research study is to see how well (compared to placebo) Enbrel® (etanercept) 50 mg twice a week for 12 weeks affects plaque psoriasis of the hands and/or feet (palmoplantar psoriasis).

Conditions

Psoriasis

Keywords

palmoplantar psoriasis; etanercept; Enbrel

Outcome Measures

Primary Outcomes (1)

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

  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 (PPPASI) 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, with 4 being the most severe.

  Week 12

Study Arms (2)

Treatment Group

EXPERIMENTAL

Etanercept (Enbrel) 50mg twice weekly injections for 12 weeks

Biological: Etanercept

Placebo Group

PLACEBO COMPARATOR

Placebo Injections twice weekly for 12 weeks

Other: Placebo injections

Interventions

Etanercept BIOLOGICAL

Subcutaneous injections 50 mg Etanercept will occur twice weekly over a 12-week treatment period.

Also known as: Enbrel

Treatment Group

Placebo injections OTHER

Placebo injections twice weekly for 12 weeks.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe palmar plantar psoriasis based on physician's global assessment (PGA).
• Between 18 and 70 years of age
• Negative urine pregnancy test at screening and at baseline
• Ability to self inject study drug or have a designee who can do so
• Capable of understanding and giving written voluntary informed consent

You may not qualify if:

• Previous treatment with Enbrel® (etanercept) or similar drugs
• Receipt of investigational drugs or "biologics" within 4 weeks of the screening visit.
• 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 initiation.
• 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

Sponsors & Collaborators

• University of California, Irvine: lead
• Amgen: collaborator

Study Sites (3)

UC Irvine Dermatology Clinical Research Center

Irvine, California, 92697, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Dermatology Associates, PLLC

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; 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: Steven Feldman, MD, PhD
• Organization: Wake Forest Baptist Health, Department of Dermatology

sfeldman@wakehealth.edu

336-716-3775

Study Officials

• Gerald D Weinstein, M.D.

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of Dermatology

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 3, 2008
• Study Start: May 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: August 18, 2023
• Results First Posted: November 8, 2011

Record last verified: 2023-08

Locations

US (3)