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This study has been withdrawn prior to enrollment.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:
Northwestern University
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
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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 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 May 19, 2013