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Efalizumab in the Treatment of Alopecia, Phase II

Primary Purpose

Alopecia Totalis

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

efalizumab

About this trial

This is an interventional treatment trial for Alopecia Totalis focused on measuring alopecia, areata, universalis, severe, ophiasis, variants

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Subjects receiving drug

Outcomes

Primary Outcome Measures

Percentage re-growth of scalp hair loss

Secondary Outcome Measures

Self-assessment (SA) and Static physician global assessment (SPGA)

Body hair re-growth at 48 weeks

Quality of life questionnaire

Full Information

NCT ID

NCT00746980

First Posted

September 2, 2008

Last Updated

June 13, 2016

Sponsor

Northwestern University

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00746980

Brief Title

Efalizumab in the Treatment of Alopecia, Phase II

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Withdrawn

Why Stopped

Newly identified safety concerns have changed the risk and benefit considerations

Study Start Date

August 2008 (undefined)

Primary Completion Date

July 2009 (Anticipated)

Study Completion Date

July 2009 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

Genentech, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alopecia Totalis

Keywords

alopecia, areata, universalis, severe, ophiasis, variants

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Subjects receiving drug

Intervention Type

Drug

Intervention Name(s)

efalizumab

Other Intervention Name(s)

Raptiva

Intervention Description

1 mg/kg subcutaneously once weekly for 48 weeks, following an initial conditioning dose of 0.7 mg/kg at week 0.

Primary Outcome Measure Information:

Title

Percentage re-growth of scalp hair loss

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Self-assessment (SA) and Static physician global assessment (SPGA)

Time Frame

1 year

Title

Body hair re-growth at 48 weeks

Time Frame

1 year

Title

Quality of life questionnaire

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dennis West, PhD

Organizational Affiliation

Northwestern University, Department of Dermatology

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Efalizumab in the Treatment of Alopecia, Phase II

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