A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata (BRAVE-AA-PEDS)
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of Baricitinib in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
Sponsor: Eli Lilly and Company
Listed as NCT05723198, this observational or N/A phase trial focuses on Alopecia and Areata Alopecia and remains actively recruiting participants. Sponsored by Eli Lilly and Company, it has been updated 28 times since 2023, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
28 versions recorded-
Apr 18, 2026 — Present [daily]
Recruiting
Phase: PHASE3 → None
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Feb 2026 — Apr 2026 [monthly]
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▶ Show 23 earlier versions
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Nov 2023 — Feb 2024 [monthly]
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Oct 2023 — Nov 2023 [monthly]
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Aug 2023 — Oct 2023 [monthly]
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Jul 2023 — Aug 2023 [monthly]
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Jun 2023 — Jul 2023 [monthly]
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May 2023 — Jun 2023 [monthly]
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Apr 2023 — May 2023 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Mar 2023 — Apr 2023 [monthly]
Not Yet Recruiting PHASE3
First recorded
Feb 2023
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility 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.
Contact Information
- Eli Lilly and Company
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Bad Bentheim, Germany , Badalona, Spain , Barcelona, Spain , Berlin, Germany , Bexley, United States , Bilbao (Bizkaia), Spain , Birmingham, United States , Birmingham, United States , Boca Raton, United States , Brest, France and 117 more locations