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Tofacitnib for the Treatment of Alopecia Areata and Variants

Primary Purpose

Alopecia Areata (AA), Alopecia Totalis (AT), Alopecia Universalis (AU)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tofacitinib Administration
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata (AA)

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

  • Yale University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tofacitinib Administration

Arm Description

5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.

Outcomes

Primary Outcome Measures

Mean Change in Severity of Alopecia Tool (SALT) Score
SALT score range is from 0 (no hair loss) to 100 (100% hair loss)

Secondary Outcome Measures

Mean Change in Skindex 16 Scores
Skindex 16 is a quality of life questionaire with a range of 0-100 wherein 1 is not bothered by the condition and 100 is always bothered by the condition

Full Information

First Posted
July 18, 2014
Last Updated
March 31, 2017
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT02197455
Brief Title
Tofacitnib for the Treatment of Alopecia Areata and Variants
Official Title
Tofacitnib for the Treatment of Alopecia Areata and Variants
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study is an open-label pilot study. Participants will be treated with oral tofacitinib for a maximum of 5 months. Participants will be evaluated at 3 months after completion of therapy to evaluate for durability of response, late response and/or late adverse effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata (AA), Alopecia Totalis (AT), Alopecia Universalis (AU)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tofacitinib Administration
Arm Type
Experimental
Arm Description
5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.
Intervention Type
Drug
Intervention Name(s)
Tofacitinib Administration
Intervention Description
5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.
Primary Outcome Measure Information:
Title
Mean Change in Severity of Alopecia Tool (SALT) Score
Description
SALT score range is from 0 (no hair loss) to 100 (100% hair loss)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mean Change in Skindex 16 Scores
Description
Skindex 16 is a quality of life questionaire with a range of 0-100 wherein 1 is not bothered by the condition and 100 is always bothered by the condition
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett King, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27699252
Citation
Kennedy Crispin M, Ko JM, Craiglow BG, Li S, Shankar G, Urban JR, Chen JC, Cerise JE, Jabbari A, Winge MC, Marinkovich MP, Christiano AM, Oro AE, King BA. Safety and efficacy of the JAK inhibitor tofacitinib citrate in patients with alopecia areata. JCI Insight. 2016 Sep 22;1(15):e89776. doi: 10.1172/jci.insight.89776.
Results Reference
derived

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Tofacitnib for the Treatment of Alopecia Areata and Variants

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