A Safety and Efficacy Study to Evaluate Efalizumab in Combination With UVB for Moderate to Severe Psoriasis

July 12, 2007 updated by: Derm Research, PLLC

An Open-Label Pilot Study to Evaluate the Efficacy and Safety of Raptiva (Efalizumab)in Combination With Narrow Band Phototherapy for the Treatment of Moderate to Severe Plaque Psoriasis.

An open label, single arm study to evaluate the study and efficacy of efalizumab in combination with NB-UVB. Weeks 1-12 efalizumab will be administered once a week in combination with NB-UVB three times per week. Weeks 13-24 efalizumab monotherapy will continue. Weeks 25-36 subjects will be followed for safety.

Study Overview

Status

Completed

Conditions

Plaque Psoriasis

Intervention / Treatment

Detailed Description

This is an open label, single arm, phase IV study to evaluate the study and efficacy of efalizumab in combination with NB-UVB. After screening, review of inclusion and exclusion criteria and obtaining informed consent, 20 subjects from two sites (10 subjects per site) will enter the study. The estimated rate of accrual is two subjects per month per site for a total of five months. The estimated date of study conclusion, including follow-up is January 2007.

Weeks 1-12 efalizumab will be administered subcutaneously once a week in combination with NB-UVB three times per week. At week 12, NB-UVB will be discontinued. Weeks 13-24 efalizumab monotherapy will continue to determine whether or not relapse occurs. Relapse is defined as a 50% decrease in total improvement in PASI score from baseline. Weeks 25-36 subjects will be followed for safety. Patients will be transitioned to appropriate treatment at the discretion of the investigator and/or observed closely.

Subjects with moderate to severe plaque psoriasis often require more than one therapy to treat their disease. Because of the different mechanisms of action, it is thought that combined efalizumab and NB-UVB may be more effective (percent subjects who achieve PASI 75 at 12 weeks) and have a more rapid onset than either treatment alone. This study will examine combining efalizumab with NB-UVB phototherapy for twelve weeks. Then, NB-UVB will be discontinued and efalizumab will be continued for an additional twelve weeks to determine if the achieved effect from combination therapy can be sustained with monotherapy.

The follow-up observation period from 25-36 weeks was chosen to permit an adequate amount of time to observe for any signs of disease rebound and/or adverse events after discontinuation of efalizumab and to insure that subjects are treated for such conditions appropriately.

Study Type

Interventional

Enrollment

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Kentucky
  - Louisville, Kentucky, United States, 40217
    - Derm Research, PLLC
- Washington
  - Seattle, Washington, United States, 98101
    - Dermatology Associates, PLLC

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subject has given informed consent
Subject is in generally good health, and an ambulatory male or female adult (18 years or older)
Subject has moderate to severe plaque psoriasis affecting greater than or equal to 5% body surface area
Subject is a candidate for efalizumab in combination with narrowband UVB phototherapy in the opinion of the assessing investigator
If a female of childbearing potential, a negative pregnancy test and commitment to the use of two forms of effective contraception (birth control) for the duration of the study are necessary
If a non-sterile male, commitment to the use of two forms of effective contraception (birth control) for the duration of the study is necessary.

Exclusion Criteria:

Subject is not in generally good health in the opinion of the investigator
Subject has a history of a phototoxic reaction
Subject has a history of NB-UVB failure or severe side effects from UVB that resulted in discontinuation of treatment
Subject has erythrodermic, pustular, inverse or guttate psoriasis
Subject is currently using other psoriasis treatments
Subject has used other psoriasis treatments, including herbal products or alternative therapies within 2 months (biologics), 1 month (systemic therapies including methotrexate, cyclosporine and acitretin, PUVA, Broadband UVB, NB-UVB, and tanning beds), or 2 weeks (topical therapies) of first dose of efalizumab or NB-UVB
Subject is currently enrolled in any other study except non-treatment, biopsy studies
Subject has a history of any form of cancer, including lymphoma, with the exception of non-melanoma skin cancer
Subject has a genetic disorder that predisposes to cancer (e.g. xeroderma pigmentosum)
Subject has a history of squamous cell cancer within the past 5 years or basal cell cancer within the past 3 months in areas that will be treated with NB-UVB
Subject has a history of significant drug or alcohol abuse
Pregnant women, nursing mothers, or women planning to become pregnant during the study
Subject with congenital or acquired immunodeficiency
Subjects planning to have prolonged exposure to the sun or tanning beds during the study which, in the investigator's clinical judgement, may modify the subject's disease severity
Subject has a history of lupus erythematosus, bullous pemphigoid or any other photosensitive condition which may worsen with NB-UVB
Subject is taking a medication that causes photosensitivity at the discretion of the investigator
Subject has an active infection or sepsis prior history or serious infection or tendency to get infections easily
Subject has an untreated positive PD
Subject has a blood disorder, aplastic anemia, bleeding tendency
Subject is allergic to efalizumab or any of its components
Subject has any other condition that, in the opinion of the investigator, makes subject a poor candidate for entry into the study
Subject will be vaccinated with live vaccines (e.g. Flu-Mist) during the study period.

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: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent subjects who reach PASI 75 at week 12. Time Frame: Week 12	Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent subjects who reach PASI 90 at weeks 12 and 24 Time Frame: Week 12 and 24	Week 12 and 24
Percent subjects who reach PASI 75 at week 24 Time Frame: Week 24	Week 24
Percent subjects who reach PASI 50 at weeks 12 and 24 Time Frame: Week 12 and 24	Week 12 and 24
Percent subjects who achieve improvement from baseline on Time Frame: Baseline, Week 12, Week 24	Baseline, Week 12, Week 24
the DLQI at weeks 12 and 24 Time Frame: Week 12 and Week 24	Week 12 and Week 24
Percent subjects who relapse between weeks 12 and 24 Time Frame: Week 12, Week 24	Week 12, Week 24

Collaborators and Investigators

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

Sponsor

Derm Research, PLLC

Collaborators

Genentech, Inc.

Dermatology Associates, PLLC

Investigators

Principal Investigator: Leon H Kircik, MD, Derm Research, PLLC
Principal Investigator: Bernard S Goffe, MD, Dermatology Associates, PLLC

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

March 1, 2006

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

March 10, 2006

First Submitted That Met QC Criteria