This trial is active, not recruiting.

Conditions alopecia areata, alopecia totalis, alopecia universalis
Treatment tofacitinib administration
Target JAK
Sponsor Stanford University
Start date December 2014
End date December 2017
Trial size 40 participants
Trial identifier NCT02312882, 31790ORO


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
tofacitinib administration
5 mg of tofacitinib will be taken by mouth twice a day for three months.

Primary Outcomes

Mean Change in Severity of Alopecia Tool (SALT) Score
time frame: 0 and 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Description This study is an open-label pilot study. Participants will be treated with oral tofacitinib for 3 months. Participants will be evaluated for 6 months after completion of therapy to evaluate for durability of response, late response and/or late adverse effects.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Stanford University.