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Efalizumab in the Treatment of Alopecia, Phase II

This study has been withdrawn prior to enrollment.
(Newly identified safety concerns have changed the risk and benefit considerations)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00746980
First Posted: September 4, 2008
Last Update Posted: June 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Dennis West, Northwestern University
  Purpose
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.

Condition Intervention Phase
Alopecia Totalis Drug: efalizumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efalizumab in the Treatment of Alopecia Totalis/Universalis in Young Adults, Phase II

Further study details as provided by Dennis West, Northwestern University:

Primary Outcome Measures:
  • Percentage re-growth of scalp hair loss [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Self-assessment (SA) and Static physician global assessment (SPGA) [ Time Frame: 1 year ]
  • Body hair re-growth at 48 weeks [ Time Frame: 1 year ]
  • Quality of life questionnaire [ Time Frame: 48 weeks ]

Enrollment: 0
Study Start Date: August 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Raptiva

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746980


Sponsors and Collaborators
Northwestern University
Genentech, Inc.
Investigators
Principal Investigator: Dennis West, PhD Northwestern University, Department of Dermatology
  More Information

Responsible Party: Dennis West, Professor in Dermatology and Pediatrics, Northwestern University
ClinicalTrials.gov Identifier: NCT00746980     History of Changes
Other Study ID Numbers: 20070823
First Submitted: September 2, 2008
First Posted: September 4, 2008
Last Update Posted: June 14, 2016
Last Verified: June 2016

Keywords provided by Dennis West, Northwestern University:
alopecia
areata
universalis
severe
ophiasis
variants

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs