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Tofacitinib for the Treatment of Alopecia Areata and Its Variants

NCT ID: NCT02312882

Last Updated: 2017-11-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-08-31

Brief Summary

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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

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This study is an open-label pilot study. Participants will be treated with oral tofacitinib for 3 months.

Conditions

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Alopecia Areata Alopecia Totalis Alopecia Universalis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tofacitinib

Participants will receive tofacitinib for 3 months.

Group Type EXPERIMENTAL

Tofacitinib

Intervention Type DRUG

Tofacitinib 5 mg tablet taken by mouth twice a day.

Interventions

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Tofacitinib

Tofacitinib 5 mg tablet taken by mouth twice a day.

Intervention Type DRUG

Other Intervention Names

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Xeljanz Jakvinus

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Anthony Oro

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anthony E Oro, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 27699252 (View on PubMed)

Other Identifiers

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IRB-31790

Identifier Type: OTHER

Identifier Source: secondary_id

31790ORO

Identifier Type: -

Identifier Source: org_study_id