Efalizumab in the Treatment of Alopecia, Phase II

Efalizumab in the Treatment of Alopecia Totalis/Universalis in Young Adults, Phase II

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.

Study Overview

• Status: Withdrawn
• Conditions: Alopecia Totalis
• Intervention / Treatment: Drug: efalizumab

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 Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Subjects receiving drug	Drug: efalizumab; 1 mg/kg subcutaneously once weekly for 48 weeks, following an initial conditioning dose of 0.7 mg/kg at week 0.; Other Names: Raptiva

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage re-growth of scalp hair loss	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Dennis West, PhD, Northwestern University, Department of Dermatology

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Anticipated): July 1, 2009
• Study Completion (Anticipated): July 1, 2009

Study Registration Dates

• First Submitted: September 2, 2008
• First Submitted That Met QC Criteria: September 3, 2008
• First Posted (Estimate): September 4, 2008

Study Record Updates

• Last Update Posted (Estimate): June 14, 2016
• Last Update Submitted That Met QC Criteria: June 13, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: severe; alopecia; variants; areata; universalis; ophiasis
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: 20070823