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 (LTE) Period, and a 4-week Post-treatment Follow-up period. Some individuals may be eligible to receive treatment after completing the LTE, for a maximum of 180 weeks.
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
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 any other concomitant conditions (for example, tinea capitis, psoriasis, lupus erythematosus, or secondary syphilis) that would interfere with evaluations of the effect of study medication on AA.
Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden
Have uncontrolled arterial hypertension
Parallel
Baricitinib
DrugAdministered orally
Placebo
DrugAdministered orally
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) ≤20
Percent Change from Baseline in SALT Score
Percentage of Participants Achieving At Least 90% Improvement from Baseline (SALT90)
Percentage of Participants Achieving an Absolute SALT ≤10
Percentage of Participants with Patient Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 Among Participants 12 Years and Older with PRO for Scalp Hair Assessment Score ≥3 at Baseline
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