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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00115076
First received: June 20, 2005
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Psoriasis
Drug: Efalizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • Clinical improvement of target lesions [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of overall clinical response [ Time Frame: Day 0, day 14, day 42, day 84, Days 112, 140, and 168 ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: October 2003
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115076

Locations
United States, New York
Rockefeller University
New York, New York, United States, 10021
Sponsors and Collaborators
Rockefeller University
Genentech
Investigators
Principal Investigator: James Krueger, MD Rockefeller University
  More Information

No publications provided by Rockefeller University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00115076     History of Changes
Other Study ID Numbers: JKR-0511
Study First Received: June 20, 2005
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Rockefeller University:
skin
psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 22, 2014