Efalizumab in the Treatment of Alopecia, Phase II

• Status: Withdrawn
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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 severe ophiasis variants.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: Genentech, Inc.
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.