What we are studying
This is a double-blind, randomized, placebo-controlled, parallel dose-comparison, multicenter study to evaluate the safety and efficacy of an investigational drug in adult patients with chronic, moderate to severe alopecia areata. Patients will be between 18 and 65 years of age and experiencing an episode of alopecia areata lasting at least 6 months and not exceeding 10 years, with at least 50% hair loss as measured by the SALT at Screening and Baseline, and are not concurrently being treated for alopecia
areata or with other treatments that might affect hair regrowth. The study is divided into 4 periods: Screening, Treatment, Dose-Adjustment, and Post-Treatment
Safety Follow-Up. The Screening Period may last up to 21 days prior to initiation of study drug. The Treatment Period is the initial 24-week, double-blind, placebo-controlled period to define primary efficacy for the study. The subsequent Dose-Adjustment Period is a 28-week, double-blind treatment period where patients tolerating treatment may adjust at Week 24 as needed to a potentially more efficacious dose, and placebo patients will begin active treatment. The Post-Treatment Safety Follow-up Period is the final 4 weeks of the study to assess safety upon active treatment completion.
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