Tofacitinib for the Treatment of Alopecia Areata and Its Variants

NCT02312882 | Completed Results

• 2 other identifiers: 31790OROIRB-31790
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata; Alopecia Totalis; Alopecia Universalis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Tofacitinib

EXPERIMENTAL

Participants will receive tofacitinib for 3 months.

Drug: Tofacitinib

Interventions

Tofacitinib DRUG

Tofacitinib 5 mg tablet taken by mouth twice a day.

Also known as: Xeljanz, Jakvinus

Tofacitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related 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 Insight. 2016 Sep 22;1(15):e89776. doi: 10.1172/jci.insight.89776.

  PMID: 27699252 RESULT

MeSH Terms

Conditions

Alopecia Areata; Alopecia universalis

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Anthony E Oro, M.D., Ph.D.
• Organization: Stanford University

oro@stanford.edu

Study Officials

• Anthony E Oro, M.D., Ph.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 9, 2014
• Study Start: December 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 6, 2017
• Results First Posted: November 6, 2017

Record last verified: 2017-10

Locations

US (1)