Status:
COMPLETED
A Safety and Efficacy Study to Evaluate Efalizumab in Combination With UVB for Moderate to Severe Psoriasis
Lead Sponsor:
Derm Research, PLLC
Collaborating Sponsors:
Dermatology Associates, PLLC
Genentech, Inc.
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 tim...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00302445
Start Date
March 1 2006
End Date
July 1 2007
Last Update
July 13 2007
Active Locations (2)
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1
Derm Research, PLLC
Louisville, Kentucky, United States, 40217
2
Dermatology Associates, PLLC
Seattle, Washington, United States, 98101