Study of the Drug Efalizumab (Raptiva), for Adult Patients With Moderate to Severe Plaque Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00115076
Recruitment Status : Completed
First Posted : June 21, 2005
Last Update Posted : June 1, 2012
Genentech, Inc.
Information provided by (Responsible Party):
Rockefeller University

Brief Summary:
Our laboratory is studying a skin disease known as psoriasis. The purpose of this protocol is to study the action and the effects of Efalizumab, on psoriasis. This medication has been studied extensively and has been found to be effective and safe in the treatment of psoriasis. The eligible patient will have 10% of his/her body surface area involved with psoriasis vulgaris.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Efalizumab Phase 3

Detailed Description:
The eligible patient will receive the drug Efalizumab, weekly for 12 weeks, by injection. The patient will be seen weekly for 12 weeks and every other week for the 12 weeks of follow up. At those visits, the patient can expect that a physical and skin exam will be done. At specific weeks, blood work will be drawn, clinical photography taken and a skin biopsy done. Two types of skin biopsies will be done after local anesthesia has been administered. One is a punch biopsy where a small piece of skin will be taken, the approximate size of a pencil eraser. The second type of skin biopsy is shave biopsy, where a postage sized piece of skin will be taken.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIIB Study to Evaluate the Mechanism of Action of 1.0 mg/kg Subcutaneously Administered Efalizumab in Adults With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy
Study Start Date : October 2003
Actual Primary Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: psoriasis
moderate to severe plaque psoriasis
Drug: Efalizumab
24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection
Other Name: Raptiva

Primary Outcome Measures :
  1. Clinical improvement of target lesions [ Time Frame: week 12 ]

Secondary Outcome Measures :
  1. Assessment of overall clinical response [ Time Frame: Day 0, day 14, day 42, day 84, Days 112, 140, and 168 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Signed informed consent

  • Plaque psoriasis covering >10% of total BSA
  • Diagnosis of plaque psoriasis for at least 6 months
  • PASI score >=12 (see Appendix A) or Linear PASI score of >= 8.0 at screening (see Appendix B)
  • In the opinion of the investigator, candidate for systemic therapy for psoriasis:

    • Who has not been previously treated (naive to systemic treatment) OR
    • Who has had prior treatment with systemic therapy for psoriasis (e.g., PUVA, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil (MMF), thioguanine, hydroxyurea, sirolimus, azathioprine, 6-MP, etanercept)
  • Body weight of <140 kg
  • 18 to 75 years old. As the risk of Efalizumab in childhood is unknown, those < 18years will be excluded from the study
  • For women of childbearing potential or in men whose partners may become pregnant, willingness to use an acceptable method of contraception to prevent pregnancy for the duration of the study (while receiving study medication and 3 months following). Acceptable methods of contraception include use of a condom; abstinence; use by sexual partner of oral implantable or injectable contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap; or a sterile sexual partner
  • Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study

Exclusion Criteria

Subjects who meet any of the following exclusion criteria are ineligible for study entry:

  • Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
  • History of severe allergic or anaphylactic reactions to humanized monoclonal antibodies or fusion proteins that contain an Ig Fc region
  • Clinically significant psoriasis flare during screening or on the first treatment day
  • Treatment with efalizumab (anti-CD11a) within the last 12 months before enrollment
  • Pregnancy or lactation. As the risk of Efalizumab in pregnancy is unknown, pregnant women will be excluded from the study
  • History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
  • History of active tuberculosis (TB) or currently undergoing treatment for TB. PPD testing or chest X-ray is required for high-risk subjects (see Appendix D).

Subjects with a positive PPD (not due to BCG vaccination) or chest X-ray will be excluded

  • History of opportunistic infections (e.g., systemic fungal infections, parasites)
  • Seropositivity for human immunodeficiency virus (HIV)
  • Seropositivity for hepatitis B or C virus
  • Hepatic enzymes >3 times the upper limits of normal (ULN)
  • Diagnosis of hepatic cirrhosis, regardless of cause or severity
  • WBC count <4000μL or >14,000/μL
  • Serum creatinine >2 times the ULN
  • Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year
  • Presence of malignancy within the past 5 years, including lymphoproliferative disorders. Subjects with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled
  • History of substance abuse within the last 5 years
  • Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug Note: Certain medications and vaccines may not be used for specified periods of time prior to enrollment or at any time during the treatment period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00115076

United States, New York
Rockefeller University
New York, New York, United States, 10021
Sponsors and Collaborators
Rockefeller University
Genentech, Inc.
Principal Investigator: James Krueger, MD Rockefeller University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Rockefeller University Identifier: NCT00115076     History of Changes
Other Study ID Numbers: JKR-0511
First Posted: June 21, 2005    Key Record Dates
Last Update Posted: June 1, 2012
Last Verified: May 2012

Keywords provided by Rockefeller University:

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs