Tofacitnib for the Treatment of Alopecia Areata and Variants

NCT02197455 | Completed Phase 2 Results

• 1 other identifier: 1407014260
• Study Type: interventional
• Target: 30
• 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 (AA); Alopecia Totalis (AT); Alopecia Universalis (AU)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean Change in Skindex 16 Scores

  3 months

Study Arms (1)

Tofacitinib Administration

EXPERIMENTAL

5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.

Drug: Tofacitinib Administration

Interventions

Tofacitinib Administration DRUG

5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.

Tofacitinib Administration

Eligibility Criteria

• Age: 18 Years - 90 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

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

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 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 DERIVED

MeSH Terms

Conditions

Alopecia Areata; Alopecia universalis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Brett King, MD
• Organization: Yale Univ School of Medicine

brett.king@yale.edu

2037854092

Study Officials

• Brett King, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 22, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 4, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)