Tofacitnib for the Treatment of Alopecia Areata and Variants

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: Alopecia Areata (AA); Alopecia Totalis (AT); Alopecia Universalis (AU)
• Intervention / Treatment: Drug: Tofacitinib Administration

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (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

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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tofacitinib Administration; 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.	Drug: Tofacitinib Administration; 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Brett King, MD, Yale University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: July 18, 2014
• First Submitted That Met QC Criteria: July 18, 2014
• First Posted (Estimate): July 22, 2014

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: March 31, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: 1407014260

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No