Efalizumab in the Treatment of Alopecia, Phase II

NCT ID: NCT00746980

Last Updated: 2016-06-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-07-31

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 severe ophiasis variants.

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 with efalizumab (Raptiva), a humanized monoclonal anti-CD11a antibody that reversibly inhibits T cell activation and migration, weekly for 48 weeks. We will assess for effect on hair and body re-growth as well as record any serious adverse events such as serious infections, thrombocytopenia, development of malignancy, and severe arthralgias to monitor for safety outcome data. Subjects will have regular physical examinations and laboratory studies throughout the study, as well as telephone interviews.

Conditions

Alopecia Totalis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Subjects receiving drug

Group Type: EXPERIMENTAL

efalizumab

Intervention Type: DRUG

1 mg/kg subcutaneously once weekly for 48 weeks, following an initial conditioning dose of 0.7 mg/kg at week 0.

Interventions

efalizumab

1 mg/kg subcutaneously once weekly for 48 weeks, following an initial conditioning dose of 0.7 mg/kg at week 0.

Intervention Type: DRUG

Other Intervention Names

Raptiva

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Dennis West

Professor in Dermatology and Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dennis West, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University, Department of Dermatology

Other Identifiers

20070823

Identifier Type: -

Identifier Source: org_study_id