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Tofacitinib for the Treatment of Alopecia Areata and Its Variants

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Stanford University

Status

Completed

Conditions

Alopecia Totalis
Alopecia Universalis
Alopecia Areata

Treatments

Drug: Tofacitinib

Study type

Interventional

Funder types

Other

Identifiers

NCT02312882
IRB-31790 (Other Identifier)
31790ORO

Details and patient eligibility

About

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.

Full description

This study is an open-label pilot study. Participants will be treated with oral tofacitinib for 3 months.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Tofacitinib
Experimental group
Description:
Participants will receive tofacitinib for 3 months.
Treatment:
Drug: Tofacitinib

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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