Clinical Trial

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
Recruiting Phase 3
View on ClinicalTrials.gov →
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 (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.
Protocol Amendment History 3 changes
minor Completion pushed: 2030-02 -> 2033-09 2026-05-21
notable Primary completion pushed: 2027-09 -> 2028-03 2026-04-18
minor Completion pushed: 2029-08 -> 2030-02 2026-04-18
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 2026-07-17