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This study has been withdrawn prior to enrollment.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:
Collaborator:
Genentech
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00746980
First received: September 2, 2008
Last updated: March 31, 2011
Last verified: March 2011
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Northwestern University:

Primary Outcome Measures:
  • Percentage re-growth of scalp hair loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-assessment (SA) and Static physician global assessment (SPGA) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Body hair re-growth at 48 weeks [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Quality of life questionnaire [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746980

Sponsors and Collaborators
Northwestern University
Genentech
Investigators
Principal Investigator: Heather Wickless, MD, MPH Northwestern University, Department of Dermatology
  More Information

No publications provided

Responsible Party: Heather Wickless, Northwestern University
ClinicalTrials.gov Identifier: NCT00746980     History of Changes
Other Study ID Numbers: 20070823
Study First Received: September 2, 2008
Last Updated: March 31, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 20, 2014