Alopecia TotalisPhase 2NCT00746980
Efalizumab in the Treatment of Alopecia, Phase II
A Phase 2 study testing efalizumab in people with Alopecia Totalis, run by Northwestern University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Alopecia Totalis
- What is being tested?
- efalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Jul 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Alopecia Totalis
- Being tested
- efalizumab
- Keywords
- alopecia, areata, universalis, severe, ophiasis, variants
- Medical subject headings
- Alopecia, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efalizumabDrug
Also called Raptiva
1 mg/kg subcutaneously once weekly for 48 weeks, following an initial conditioning dose of 0.7 mg/kg at week 0.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects receiving drug Receives: Drug: efalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage re-growth of scalp hair loss
Measured: 1 year
Secondary outcomes (3)
Self-assessment (SA) and Static physician global assessment (SPGA)
Measured: 1 year
Body hair re-growth at 48 weeks
Measured: 1 year
Quality of life questionnaire
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (estimated)
Why it stopped: Newly identified safety concerns have changed the risk and benefit considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia TotalisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Dennis West, Northwestern University
- Investigators
- Dennis West, PhD, Principal investigator, Northwestern University, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746980
- Sponsor's protocol ID
- 20070823
- Status last verified
- Jun 2016
- First submitted
- 2 Sep 2008
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efalizumab in the Treatment of Alopecia Totalis/Universalis in Young Adults, Phase II
- ClinicalTrials.gov ID
- NCT00746980
- Acronym / sponsor ID
- 20070823
- Conditions
- Alopecia Totalis
- Keywords
- alopecia, areata, universalis, severe, ophiasis, variants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Newly identified safety concerns have changed the risk and benefit considerations
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Aug 2008
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 4 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: efalizumabSubjects receiving drug |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| efalizumabAlso: Raptiva1 mg/kg subcutaneously once weekly for 48 weeks, following an initial conditioning dose of 0.7 mg/kg at week 0. | Drug | Treatment |
Primary outcome
Percentage re-growth of scalp hair loss
Time frame: 1 year
3 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis West, PhD principal investigator
Northwestern University, Department of Dermatology
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing efalizumab in people with Alopecia Totalis, run by Northwestern University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage re-growth of scalp hair loss (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2016.