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Sponsors and Collaborators: |
Derm Research, PLLC Dermatology Associates, PLLC Genentech |
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Information provided by: | Derm Research, PLLC |
ClinicalTrials.gov Identifier: | NCT00302445 |
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.
Condition | Intervention | Phase |
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Plaque Psoriasis |
Drug: Efalizumab Device: Narrow Band Phototherapy |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 20 |
Study Start Date: | March 2006 |
Study Completion Date: | July 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Kentucky | |
Derm Research, PLLC | |
Louisville, Kentucky, United States, 40217 | |
United States, Washington | |
Dermatology Associates, PLLC | |
Seattle, Washington, United States, 98101 |
Principal Investigator: | Leon H Kircik, MD | Derm Research, PLLC |
Principal Investigator: | Bernard S Goffe, MD | Dermatology Associates, PLLC |
Study ID Numbers: | ACD3588s |
Study First Received: | March 10, 2006 |
Last Updated: | July 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00302445 History of Changes |
Health Authority: | United States: Institutional Review Board |
Skin Diseases Psoriasis Skin Diseases, Papulosquamous |
Skin Diseases Psoriasis Skin Diseases, Papulosquamous |