Eukarya Pharmasite | Monterrey, Mexico
Status and phase
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About
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.
Enrollment
Sex
Ages
Volunteers
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.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
595 participants in 3 patient groups, including a placebo group
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Central trial contact
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Data sourced from clinicaltrials.gov
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