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Tofacitinib for the Treatment of Alopecia Areata and Its Variants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02312882
Recruitment Status : Completed
First Posted : December 9, 2014
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Anthony Oro, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alopecia Areata Alopecia Totalis Alopecia Universalis Drug: Tofacitinib Not Applicable

Detailed Description:
This study is an open-label pilot study. Participants will be treated with oral tofacitinib for 3 months.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tofacitinib for the Treatment of Alopecia Areata and Its Variants
Study Start Date : December 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tofacitinib
Participants will receive tofacitinib for 3 months.
 Drug: Tofacitinib
Tofacitinib 5 mg tablet taken by mouth twice a day.
Other Names:
  • Xeljanz
  • Jakvinus


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change in Severity of Alopecia Tool (SALT) Score [ Time Frame: 0 and 3 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02312882


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Anthony E Oro, M.D., Ph.D. Stanford University
More Information
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Publications of Results:

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Responsible Party: Anthony Oro, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02312882    
Other Study ID Numbers: 31790ORO
IRB-31790 ( Other Identifier: Stanford University )
First Posted: December 9, 2014    Key Record Dates
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
 Pathological Conditions, Anatomical
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action