NCT05723198

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 595 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Areata Alopecia
• Alopecia
• Hypotrichosis
• Hair Diseases
• Skin Diseases
• Pathological Conditions, Anatomical

Interventions

Type	Name	Description
DRUG	Baricitinib	Administered orally
DRUG	Placebo	Administered orally

Timeline

• Start date: 2023-02-27
• Primary completion: 2028-03-01
• Completion: 2030-02-01
• First posted: 2023-02-10
• Last updated: 2026-04-17

Locations

127 sites across 12 countries: United States, Argentina, Australia, Canada, France, Germany, Hungary, Japan, Poland, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study