Status:
WITHDRAWN
Efalizumab in the Treatment of Alopecia, Phase II
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Alopecia Totalis
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
Brief Summary
Determine the effect that treatment with efalizumab has on scalp hair re-growth in younger adults affected by severe variants of alopecia areata, including alopecia totalis, alopecia universalis, and ...
Detailed Description
This is a Phase II trial (single-center, open-label, prospective study) where subjects with severe forms of alopecia areata, namely alopecia totalis, universalis, and severe ophiasis, will be treated ...
Eligibility Criteria
Inclusion
- ability to provide written informed consent and comply with study assessments for the full duration of the study.
- clinical diagnosis of alopecia totalis, alopecia universalis, or severe ophiasis variant of alopecia areata.
- 18-40 years of age.
- 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
- known hypersensitivity to efalizumab (Raptiva) or any of its components.
- known liver disease, including active hepatitis
- history of autoimmune diseases causing alopecia other than alopecia areata.
- prior biologic therapy within 6 months prior to study initiation.
- history of any malignancy within last ten years, except treated non-melanoma skin cancers.
- any woman currently pregnant or lactating.
- intake of systemic immunosuppressive agents, including oral corticosteroids, within 3 months prior to study initiation.
- history of positive PPD and/or tuberculosis.
- history of HIV/AIDS
- prior enrollment in any efalizumab study
- any condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
- participation in another simultaneous clinical trial involving investigational agents.
- positive HIV screening test obtained at screening visit.
- positive QuantiFERON-TB test obtained at screening visit.
- positive hepatitis screen obtained at screening visit.
- platelet count 150 x 10(9)/L at baseline visit.
- presence of any abnormal laboratory value obtained at screening visit assessed as clinically significant by principal investigator.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00746980
Start Date
August 1 2008
End Date
July 1 2009
Last Update
June 14 2016
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