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

This study has been completed.
Sponsor:
Collaborators:
Dermatology Associates, PLLC
Genentech
Information provided by:
Derm Research, PLLC
ClinicalTrials.gov Identifier:
NCT00302445
First received: March 10, 2006
Last updated: July 12, 2007
Last verified: July 2007
  Purpose

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
Plaque Psoriasis
Drug: Efalizumab
Device: Narrow Band Phototherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Derm Research, PLLC:

Primary Outcome Measures:
  • Percent subjects who reach PASI 75 at week 12. [ Time Frame: Week 12 ]

Secondary Outcome Measures:
  • Percent subjects who reach PASI 90 at weeks 12 and 24 [ Time Frame: Week 12 and 24 ]
  • Percent subjects who reach PASI 75 at week 24 [ Time Frame: Week 24 ]
  • Percent subjects who reach PASI 50 at weeks 12 and 24 [ Time Frame: Week 12 and 24 ]
  • Percent subjects who achieve improvement from baseline on [ Time Frame: Baseline, Week 12, Week 24 ]
  • the DLQI at weeks 12 and 24 [ Time Frame: Week 12 and Week 24 ]
  • Percent subjects who relapse between weeks 12 and 24 [ Time Frame: Week 12, Week 24 ]

Estimated Enrollment: 20
Study Start Date: March 2006
Study Completion Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302445

Locations
United States, Kentucky
Derm Research, PLLC
Louisville, Kentucky, United States, 40217
United States, Washington
Dermatology Associates, PLLC
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Derm Research, PLLC
Dermatology Associates, PLLC
Genentech
Investigators
Principal Investigator: Leon H Kircik, MD Derm Research, PLLC
Principal Investigator: Bernard S Goffe, MD Dermatology Associates, PLLC
  More Information

Publications:
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

ClinicalTrials.gov Identifier: NCT00302445     History of Changes
Other Study ID Numbers: ACD3588s
Study First Received: March 10, 2006
Last Updated: July 12, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 10, 2014