A Study to Evaluate Raptiva in Combination With Topical Psoriasis Therapies

June 19, 2013 updated by: Genentech, Inc.

An Open Label, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneously Administered Efalizumab Used in Combination With Topical Psoriasis Therapies for Prolonged Maintenance Treatment

This study is an open label, randomized, multicenter study designed to compare the efficacy of 12 weeks of subcutaneously administered efalizumab (monotherapy) with that of combination therapy (Efalizumab and a topical corticosteroid ointment) in subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy. The study will also evaluate the safety and tolerability of 30 months of continuous efalizumab treatment in those subjects who derive benefit from the initial 12 weeks of treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent
  • Diagnosis of plaque psoriasis for >=6 months
  • A minimum Psoriasis Area and Severity Index (PASI) score of 12.0 at screening
  • Plaque psoriasis covering >=10% of total Body Surface Area (BSA)
  • 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 received prior systemic therapy for psoriasis (e.g., PUVA, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil [MMF], thioguanine, hydroxyurea, sirolimus, azathioprine, 6 MP, etanercept)
  • 18 to 70 years old

Exclusion Criteria:

  • Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
  • Clinically significant psoriasis flare during the 3 months prior to enrollment
  • Pregnancy or lactation
  • History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
  • History of opportunistic infections (e.g., systemic fungal infections, parasites)
  • Seropositivity for hepatitis B or C virus
  • Seropositivity for human immunodeficiency virus (HIV)
  • History of active tuberculosis (TB) or currently undergoing treatment for TB
  • Presence or history of malignancy within the past 5 years, including lymphoproliferative disorders
  • Diagnosis of hepatic cirrhosis, regardless of cause or severity
  • Hospital admission for cardiovascular or pulmonary disease within the last year
  • History of substance abuse within the last 5 years
  • History of severe allergic or anaphylactic reactions to monoclonal antibodies or fusion proteins, which contain an immunoglobulin (Ig) Fc region (e.g., etanercept, LFA3TIP)
  • History of severe allergic reactions to or intolerance of topical corticosteroid therapies
  • Previous treatment with efalizumab
  • History of treatment with lymphocyte-depleting monoclonal antibodies or immunoadhesion molecules (e.g., anti-CD4, CTLA4-Ig, LFA3TIP)
  • WBC count <4000/uL or >14,000/uL
  • Hepatic enzymes >=3 times the upper limit of normal
  • Creatinine >=2 times the upper limit of normal
  • Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug
  • Any medical or other condition that, in the judgment of the investigator, would significantly interfere with the subject's ability to comply with the provisions of this protocol
  • Topical therapy for psoriasis
  • Systemic therapy for psoriasis
  • Systemic immunosuppressive drugs
  • Tanning beds, booths, or home UV light sources
  • Live virus or bacteria vaccine
  • Other vaccines or allergy desensitization injections
  • Other experimental drugs or treatments
  • Nonsteroidal anti inflammatory drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Study Completion (Actual)

May 1, 2004

Study Registration Dates

First Submitted

November 17, 2004

First Submitted That Met QC Criteria

November 17, 2004

First Posted (Estimate)

November 18, 2004

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 19, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACD2243g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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