A Safety and Efficacy Study to Evaluate Efalizumab in Combination With UVB for Moderate to Severe Psoriasis
NCT ID: NCT00302445
Last Updated: 2007-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2006-03-31
2007-07-31
Brief Summary
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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 and have a more rapid onset than either treatment alone.
Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Efalizumab
Narrow Band Phototherapy
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
Yes
Sponsors
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Dermatology Associates, PLLC
UNKNOWN
Genentech, Inc.
INDUSTRY
Derm Research, PLLC
OTHER
Principal Investigators
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Leon H Kircik, MD
Role: PRINCIPAL_INVESTIGATOR
Derm Research, PLLC
Bernard S Goffe, MD
Role: PRINCIPAL_INVESTIGATOR
Dermatology Associates, PLLC
Locations
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Derm Research, PLLC
Louisville, Kentucky, United States
Dermatology Associates, PLLC
Seattle, Washington, United States
Countries
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References
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Berneburg M, Rocken M, Benedix F. Phototherapy with narrowband vs broadband UVB. Acta Derm Venereol. 2005;85(2):98-108. doi: 10.1080/00015550510025579.
Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. doi: 10.1159/000250839.
Gupta G, Long J, Tillman DM. The efficacy of narrowband ultraviolet B phototherapy in psoriasis using objective and subjective outcome measures. Br J Dermatol. 1999 May;140(5):887-90. doi: 10.1046/j.1365-2133.1999.02820.x.
Ibbotson SH, Bilsland D, Cox NH, Dawe RS, Diffey B, Edwards C, Farr PM, Ferguson J, Hart G, Hawk J, Lloyd J, Martin C, Moseley H, McKenna K, Rhodes LE, Taylor DK; British Association of Dermatologists. An update and guidance on narrowband ultraviolet B phototherapy: a British Photodermatology Group Workshop Report. Br J Dermatol. 2004 Aug;151(2):283-97. doi: 10.1111/j.1365-2133.2004.06128.x.
Weischer M, Blum A, Eberhard F, Rocken M, Berneburg M. No evidence for increased skin cancer risk in psoriasis patients treated with broadband or narrowband UVB phototherapy: a first retrospective study. Acta Derm Venereol. 2004;84(5):370-4. doi: 10.1080/00015550410026948.
Werther WA, Gonzalez TN, O'Connor SJ, McCabe S, Chan B, Hotaling T, Champe M, Fox JA, Jardieu PM, Berman PW, Presta LG. Humanization of an anti-lymphocyte function-associated antigen (LFA)-1 monoclonal antibody and reengineering of the humanized antibody for binding to rhesus LFA-1. J Immunol. 1996 Dec 1;157(11):4986-95.
Fitzpatrick T and Ortonne JP in Fitzpatrick's Dermatology in General Medicine, Editors: Freedberg IM, Eisen AZ, Wolff K, Austen KF, Goldsmith LA, Katz, SI, 6th Edition 2003 McGraw-Hill; Chapter 88, Page 819
Sminkels OQ, Prins M, Veeniiuis RT, De Boo T, Gerritsen MJ, Van Der Wilt GJ, Van De Kerkhof PC, Van Der Valk PG. Effectiveness and side effects of UVB-phototherapy, dithranol inpatient therapy and a care instruction programme of short contact dithranol in moderate to severe psoriasis. Eur J Dermatol. 2004 May-Jun;14(3):159-65.
Other Identifiers
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ACD3588s
Identifier Type: -
Identifier Source: org_study_id