Tofacitnib for the Treatment of Alopecia Areata and Variants

Alopecia Areata (AA) Clinical Trial

Official title:

Tofacitnib for the Treatment of Alopecia Areata and Variants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197455
• Other study ID #: 1407014260
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2014
• Last updated: March 31, 2017
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: March 2017
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Tofacitinib Administration
5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Severity of Alopecia Tool (SALT) Score	SALT score range is from 0 (no hair loss) to 100 (100% hair loss)	3 months
Secondary	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	3 months