Tofacitinib for the Treatment of Alopecia Areata and Its Variants

October 4, 2017 updated by: Anthony Oro, Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Anthony E Oro, M.D., Ph.D., Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

December 5, 2014

First Posted (Estimate)

December 9, 2014

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

October 4, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31790ORO
  • IRB-31790 (Other Identifier: Stanford University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alopecia Areata

Clinical Trials on Tofacitinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe