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

Recruiting in Palo Alto (17 mi)

Overseen byJulian Mackay-Wiggan, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Columbia University

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Julian Mackay-Wiggan, MD, MS

Principal Investigator

Columbia University

Eligibility Criteria

Inclusion Criteria

Patients between 18 and 65 years of age.

Patients with a diagnosis of moderate to severe patch type alopecia areata.

Patients with alopecia totalis or universalis may be enrolled.

See 7 more

Treatment Details

Interventions

Tofacitinib (Janus Kinase (JAK) Inhibitor)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: TofacitinibExperimental Treatment1 Intervention

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.