Tofacitinib for the Treatment of Alopecia Areata and Its Variants

Alopecia Areata Clinical Trial

Official title:

Tofacitinib for the Treatment of Alopecia Areata and Its Variants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312882
• Other study ID #: 31790ORO
• Secondary ID: IRB-31790
• Status: Completed
• Phase: N/A
• First received: December 5, 2014
• Last updated: October 4, 2017
• Start date: December 2014
• Est. completion date: August 2015

Study information

• Verified date: October 2017
• Source: Stanford 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 3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

• 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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Alopecia Totalis
• Alopecia Universalis

Intervention

Drug:
• Tofacitinib
Tofacitinib 5 mg tablet taken by mouth twice a day.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 I — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Severity of Alopecia Tool (SALT) Score	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