A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
This study tests a medication called baricitinib to see if it can help children ages 6-17 with severe hair loss (alopecia areata) regrow their hair. The study lasts several months and includes regular check-ins with doctors to monitor how well the medication works and any side effects.
Key Objective:The trial is testing whether baricitinib can help children with severe alopecia areata regrow hair and stop further hair loss.
Who to Consider:Children ages 6 to less than 18 years old with severe or very severe alopecia areata who are interested in trying a new treatment approach should consider enrolling.
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The main purpose of this study is to determine the efficacy and safety of baricitinib for the treatment of severe or very severe alopecia areata (hair loss) in children from 6 years to less than 18 years of age. The study is divided into 4 periods, a 5-week Screening period, a 36-week Double-Blind Treatment Period, an approximately 2-year Long-term Extension Period, and a 4-week Post-treatment Follow-up period.
Eligibility Criteria
Inclusion Criteria: * Enrollment will be fully sequential by age group, with adolescents (12 to less than 18 years old) enrolling before children (6 to less than 12 years old). * Have severe areata alopecia (AA) for at least 1 year * Diagnosis for at least 1 year * Current AA episode of at least 6 months' duration * SALT score ≥50% at screening and baseline * History of trial and failure with at least 1 available treatment (topical or other) for AA * History of psychological counseling related to AA * Current episode of severe AA of less than 8 years. * Note: Participants who have severe AA for ≥8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years. Exclusion Criteria: * Primarily "diffuse" type of AA (characterized by diffuse hair shedding). * Are currently experiencing other forms of alopecia including, but not limited to trichotillomania, telogen effluvium, chemotherapy-induced hair loss, or an