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

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Efalizumab
Narrow Band Phototherapy
Sponsored by
Derm Research, PLLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Derm Research, PLLC
  • Dermatology Associates, PLLC

Outcomes

Primary Outcome Measures

Percent subjects who reach PASI 75 at week 12.

Secondary Outcome Measures

Percent subjects who reach PASI 90 at weeks 12 and 24
Percent subjects who reach PASI 75 at week 24
Percent subjects who reach PASI 50 at weeks 12 and 24
Percent subjects who achieve improvement from baseline on
the DLQI at weeks 12 and 24
Percent subjects who relapse between weeks 12 and 24

Full Information

First Posted
March 10, 2006
Last Updated
July 12, 2007
Sponsor
Derm Research, PLLC
Collaborators
Dermatology Associates, PLLC, Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00302445
Brief Title
A Safety and Efficacy Study to Evaluate Efalizumab in Combination With UVB for Moderate to Severe Psoriasis
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Derm Research, PLLC
Collaborators
Dermatology Associates, PLLC, Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 times per week. Weeks 13-24 efalizumab monotherapy will continue. Weeks 25-36 subjects will be followed for safety. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Efalizumab
Intervention Type
Device
Intervention Name(s)
Narrow Band Phototherapy
Primary Outcome Measure Information:
Title
Percent subjects who reach PASI 75 at week 12.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percent subjects who reach PASI 90 at weeks 12 and 24
Time Frame
Week 12 and 24
Title
Percent subjects who reach PASI 75 at week 24
Time Frame
Week 24
Title
Percent subjects who reach PASI 50 at weeks 12 and 24
Time Frame
Week 12 and 24
Title
Percent subjects who achieve improvement from baseline on
Time Frame
Baseline, Week 12, Week 24
Title
the DLQI at weeks 12 and 24
Time Frame
Week 12 and Week 24
Title
Percent subjects who relapse between weeks 12 and 24
Time Frame
Week 12, Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon H Kircik, MD
Organizational Affiliation
Derm Research, PLLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bernard S Goffe, MD
Organizational Affiliation
Dermatology Associates, PLLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Derm Research, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Dermatology Associates, PLLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15823900
Citation
Berneburg M, Rocken M, Benedix F. Phototherapy with narrowband vs broadband UVB. Acta Derm Venereol. 2005;85(2):98-108. doi: 10.1080/00015550510025579.
Results Reference
background
PubMed Identifier
357213
Citation
Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. doi: 10.1159/000250839.
Results Reference
background
PubMed Identifier
10354027
Citation
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.
Results Reference
background
PubMed Identifier
15327535
Citation
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.
Results Reference
background
PubMed Identifier
15370703
Citation
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.
Results Reference
background
PubMed Identifier
8943405
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
15246941
Citation
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.
Results Reference
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A Safety and Efficacy Study to Evaluate Efalizumab in Combination With UVB for Moderate to Severe Psoriasis

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