Tofacitnib for the Treatment of Alopecia Areata and Variants

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Tofacitinib

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

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