Tofacitnib for the Treatment of Alopecia Areata and Variants

Phase 2

Completed

• Conditions: Alopecia Universalis (AU); Alopecia Areata (AA); Alopecia Totalis (AT)
• Interventions: Drug: Tofacitinib Administration

• Registration Number: NCT02197455
• Lead Sponsor: Yale University

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-18
• Study First Submitted QC: 2014-07-18
• Study First Posted: 2014-07-22
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Results First Submitted: 2017-01-30
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-31
• Last Update Submitted: 2017-03-31
• Results First Posted: 2017-04-04
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tofacitinib Administration	Tofacitinib Administration	5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.

Primary Outcome Measures

Name	Time	Method
Mean Change in Severity of Alopecia Tool (SALT) Score	3 months	SALT score range is from 0 (no hair loss) to 100 (100% hair loss)

Secondary Outcome Measures

Name	Time	Method
Mean Change in Skindex 16 Scores	3 months	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

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States