Back to resultsTofacitinib for the Treatment of Alopecia Areata and Its Variants
Primary Purpose
Alopecia Areata, Alopecia Totalis, Alopecia Universalis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tofacitinib
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia Areata
Eligibility Criteria
Inclusion Criteria:
- Age >= 18 years old
- Diagnosis of alopecia areata with >50% scalp involvement, alopecia totalis, or alopecia universalis
- Hair loss present for at least 6 months
- No treatment for alopecia areata in past 2 months
- No evidence of hair regrowth
- Females of childbearing potential must use birth control while taking the medication and there must be a negative pregnancy test documented prior to starting the medication
- Fluent in spoken and written English
Exclusion Criteria:
- Age <18 years old
- Patients have received treatment known to affect alopecia areata within 2 months of enrolling in the study
- Patients with a history of malignancy (except history of successfully treated basal cell or squamous cell carcinoma of the skin)
- Patients known to be HIV or hepatitis B or C positive
- Patients with positive tuberculin skin test or positive QuantiFERON TB test
- Patients with leukopenia or anemia
- Patients with renal or hepatic impairment
- Patients with peptic ulcer disease
- Patients taking immunosuppressive medications, including but not limited to prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or TNH-alpha inhibitors
- Women of childbearing potential who are unable or unwilling to use birth control while taking the medication
- Women who are pregnant or nursing
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tofacitinib
Arm Description
Participants will receive tofacitinib for 3 months.
Outcomes
Primary Outcome Measures
Percent Change in Severity of Alopecia Tool (SALT) Score
SALT score range is from 0 (no hair loss) to 100 (100% hair loss). Positive percent change from baseline corresponds to reduction in SALT score.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02312882
Brief Title
Tofacitinib for the Treatment of Alopecia Areata and Its Variants
Official Title
Tofacitinib for the Treatment of Alopecia Areata and Its Variants
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia areata and its variants.
Detailed Description
This study is an open-label pilot study. Participants will be treated with oral tofacitinib for 3 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata, Alopecia Totalis, Alopecia Universalis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tofacitinib
Arm Type
Experimental
Arm Description
Participants will receive tofacitinib for 3 months.
Intervention Type
Drug
Intervention Name(s)
Tofacitinib
Other Intervention Name(s)
Xeljanz, Jakvinus
Intervention Description
Tofacitinib 5 mg tablet taken by mouth twice a day.
Primary Outcome Measure Information:
Title
Percent Change in Severity of Alopecia Tool (SALT) Score
Description
SALT score range is from 0 (no hair loss) to 100 (100% hair loss). Positive percent change from baseline corresponds to reduction in SALT score.
Time Frame
0 and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >= 18 years old
Diagnosis of alopecia areata with >50% scalp involvement, alopecia totalis, or alopecia universalis
Hair loss present for at least 6 months
No treatment for alopecia areata in past 2 months
No evidence of hair regrowth
Females of childbearing potential must use birth control while taking the medication and there must be a negative pregnancy test documented prior to starting the medication
Fluent in spoken and written English
Exclusion Criteria:
Age <18 years old
Patients have received treatment known to affect alopecia areata within 2 months of enrolling in the study
Patients with a history of malignancy (except history of successfully treated basal cell or squamous cell carcinoma of the skin)
Patients known to be HIV or hepatitis B or C positive
Patients with positive tuberculin skin test or positive QuantiFERON TB test
Patients with leukopenia or anemia
Patients with renal or hepatic impairment
Patients with peptic ulcer disease
Patients taking immunosuppressive medications, including but not limited to prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or TNH-alpha inhibitors
Women of childbearing potential who are unable or unwilling to use birth control while taking the medication
Women who are pregnant or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony E Oro, M.D., Ph.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27699252
Citation
Kennedy Crispin M, Ko JM, Craiglow BG, Li S, Shankar G, Urban JR, Chen JC, Cerise JE, Jabbari A, Winge MC, Marinkovich MP, Christiano AM, Oro AE, King BA. Safety and efficacy of the JAK inhibitor tofacitinib citrate in patients with alopecia areata. JCI Insight. 2016 Sep 22;1(15):e89776. doi: 10.1172/jci.insight.89776.
Results Reference
result
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Tofacitinib for the Treatment of Alopecia Areata and Its Variants
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