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

NCT00302445 | Completed Phase 4 DMC

• 1 other identifier: ACD3588s
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percent subjects who reach PASI 75 at week 12.

  Week 12

Secondary Outcomes (6)

• Percent subjects who reach PASI 90 at weeks 12 and 24

  Week 12 and 24

• Percent subjects who reach PASI 75 at week 24

  Week 24

• Percent subjects who reach PASI 50 at weeks 12 and 24

  Week 12 and 24

• Percent subjects who achieve improvement from baseline on

  Baseline, Week 12, Week 24

• the DLQI at weeks 12 and 24

  Week 12 and Week 24

Interventions

Efalizumab DRUG

Narrow Band Phototherapy DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Derm Research, PLLC: lead
• Dermatology Associates, PLLC: collaborator
• Genentech, Inc.: collaborator

Study Sites (2)

Derm Research, PLLC

Louisville, Kentucky, 40217, United States

Location

Dermatology Associates, PLLC

Seattle, Washington, 98101, United States

Location

Related Publications (8)

• Berneburg M, Rocken M, Benedix F. Phototherapy with narrowband vs broadband UVB. Acta Derm Venereol. 2005;85(2):98-108. doi: 10.1080/00015550510025579.

  PMID: 15823900 BACKGROUND

• Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. doi: 10.1159/000250839.

  PMID: 357213 BACKGROUND

• 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.

  PMID: 10354027 BACKGROUND

• 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.

  PMID: 15327535 BACKGROUND

• 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.

  PMID: 15370703 BACKGROUND

• 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.

  PMID: 8943405 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 15246941 BACKGROUND

MeSH Terms

Interventions

efalizumab

Study Officials

• Leon H Kircik, MD

  Derm Research, PLLC

  PRINCIPAL INVESTIGATOR

• Bernard S Goffe, MD

  Dermatology Associates, PLLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 10, 2006
• First Posted: March 14, 2006
• Study Start: March 1, 2006
• Study Completion: July 1, 2007
• Last Updated: July 13, 2007

Record last verified: 2007-07

Locations

US (2)