Efalizumab in the Treatment of Alopecia, Phase II

Phase 2

Withdrawn

• Conditions: Alopecia Totalis
• Interventions: Drug: efalizumab

• Registration Number: NCT00746980
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-02
• Study First Submitted QC: 2008-09-03
• Study First Posted: 2008-09-04
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-13
• Last Update Posted: 2016-06-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	efalizumab	Subjects receiving drug

Primary Outcome Measures

Name	Time	Method
Percentage re-growth of scalp hair loss	1 year

Secondary Outcome Measures

Name	Time	Method
Body hair re-growth at 48 weeks	1 year
Quality of life questionnaire	48 weeks
Self-assessment (SA) and Static physician global assessment (SPGA)	1 year