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A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata

Study acronym: BRAVE-AA-PEDS
StatusRecruiting
PhasePhase 3
Started2023-02-27
View on ClinicalTrials.gov ↗
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.

Amendment history 3 changes detected by DataLookout

2026-05-21
Completion pushed: 2030-02 → 2033-09
2026-04-18
Primary completion pushed: 2027-09 → 2028-03
2026-04-18
Completion pushed: 2029-08 → 2030-02
Trial Details
NCT Number NCT05723198
Lead Sponsor Eli Lilly and Company
Conditions Areata Alopecia, Alopecia, Hypotrichosis, Hair Diseases, Skin Diseases, Pathological Conditions, Anatomical
Enrollment 595 participants
Start Date 2023-02-27
Primary Completion 2028-03 (estimated)
Study Completion 2033-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-08