Study To Evaluate The Efficacy Of Tofacitinib In Moderate To Severe Alopecia Areata, Totalis And Universalis

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT02299297
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib — DRUG
    Dosage/Frequency: 5mg - 10mg, oral, twice daily

Study Details

This is an open-label pilot study of tofacitinib taken daily for 6 months in the treatment of moderate to severe AA, and alopecia totalis or universalis, followed by 6 months follow-up off drug to assess the incidence and timing of recurrence of disease or documentation of delayed response to treatment. There will be the option of increasing the treatment duration up to an additional 6 months beyond the initially scheduled 6 months of treatment, if clinically indicated, and at the discretion of the investigator.

Key Dates

Start date
Jan 31, 2015
Status verified
Apr 2019
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tofacitinib
    Tofacitinib will be self-administered for 6 months, with the option to extend treatment up to an additional 6 months at the discretion of the principal investigator. Patients will then be followed for 6 months off the drug to assess the incidence and timing of recurrence of disease or documentation of delayed response to treatment.

Primary Outcome Measure

Total Number of Responders [ Time Frame: Baseline up to between 24 and 72 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032-

Find similar trials in New York, NY

By research site
Columbia University Medical Center· New York, NY

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