Actively Recruiting
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Baricitinib in Children Ages 6 to Less Than 18 Years With Alopecia Areata
Led by Eli Lilly and Company · Updated on 2026-05-20
595
Participants Needed
127
Research Sites
287 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of baricitinib for treating severe or very severe alopecia areata, a condition causing hair loss, in children aged 6 to less than 18 years. This Phase 3 clinical trial aims to determine how well baricitinib works in this young population, with careful monitoring of outcomes related to hair regrowth and patient well-being. Participants will be randomly assigned to one of three groups a high dose of baricitinib, a low dose of baricitinib, or a placebo. The study includes four periods a 5-week screening phase to determine eligibility, a 36-week double-blind treatment period where participants receive their assigned treatment, an approximately 2-year long-term extension to observe longer-term effects, and a 4-week follow-up after treatment ends. Some participants may continue to receive treatment after the extension for up to 180 weeks. During the trial, children will undergo regular assessments including the Severity of Alopecia Tool SALT score to measure hair loss, patient-reported outcomes on scalp hair, eyebrow, and eyelash hair, as well as evaluations of anxiety, depression, and quality of life. Blood tests will monitor drug levels and immune response. Participants will be closely followed throughout the study periods to track changes and ensure safety, with the total participation lasting over two years depending on extension eligibility.
CONDITIONS
Brief Title
A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 to less than 18 years
- Diagnosed with severe alopecia areata for at least 1 year
- Current alopecia areata episode lasting at least 6 months
- SALT score of 50% or higher at screening and baseline
- History of failure with at least one available treatment for alopecia areata
- History of psychological counseling related to alopecia areata
- Current episode of severe alopecia areata less than 8 years in duration (exceptions allowed if regrowth episodes observed)
You will not qualify if you...
- Primarily diffuse type of alopecia areata with diffuse hair shedding
- Currently experiencing other forms of alopecia or related conditions interfering with study evaluation
- Largely or wholly incapacitated with little or no self-care ability
- Uncontrolled high blood pressure
- Major surgery within 8 weeks prior to screening or planned major surgery during the study
- History or presence of serious or unstable illnesses that increase risk or interfere with study
- Positive test for hepatitis B virus infection
- Hepatitis C virus infection confirmed by RNA test
- Evidence of HIV infection or positive HIV antibodies
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Physicians interested in becoming principal investigators please contact
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