Tofacitnib for the Treatment of Alopecia Areata and Variants

Study Overview
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Brief Summary
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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
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This study is an open-label pilot study. Participants will be treated with oral tofacitinib for a maximum of 5 months. Participants will be evaluated at 3 months after completion of therapy to evaluate for durability of response, late response and/or late adverse effects.

Official Title
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Tofacitnib for the Treatment of Alopecia Areata and Variants

Conditions
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Alopecia Areata (AA), Alopecia Totalis (AT), Alopecia Universalis (AU)

Intervention / Treatment
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* Drug: Tofacitinib Administration


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tofacitinib Administration<br>5 mg of Tofacitinib will be taken by mouth twice daily for 3 months. | Drug: Tofacitinib Administration<br>* 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Severity of Alopecia Tool (SALT) Score | SALT score range is from 0 (no hair loss) to 100 (100% hair loss) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Skindex 16 Scores | Skindex 16 is a quality of life questionaire with a range of 0-100 wherein 1 is not bothered by the condition and 100 is always bothered by the condition | 3 months |