Phase 3 Study of Baricitinib for Treating Severe Alopecia Areata in Children Aged 6 to Under 18 Years

What this Trial Is About

Researchers are evaluating the effectiveness and safety of baricitinib for treating severe or very severe alopecia areata, a form of hair loss, in children aged 6 to less than 18 years. This Phase 3 clinical trial aims to better understand how baricitinib works in this young population with this condition. The study is sponsored by Eli Lilly and Company and focuses on pediatric patients with a history of severe alopecia areata. Participants are randomly assigned to receive either a high dose or low dose of baricitinib taken orally, or a placebo. The study is divided into four periods a 5-week screening period to determine eligibility, a 36-week double-blind treatment period where participants receive the assigned study medication, an approximately 2-year long-term extension period for ongoing treatment, and a 4-week post-treatment follow-up. Some participants may continue treatment for up to a total of 180 weeks if eligible after the extension period. Throughout the study, participants undergo regular assessments including measurement of hair loss severity using the Severity of Alopecia Tool SALT score, patient-reported outcomes related to scalp hair and eyebroweyelash hair loss, and quality of life questionnaires. Safety and pharmacokinetics of baricitinib are also monitored. The primary outcome is to measure the percentage of participants achieving a SALT score of 20 or less by week 36. Participants receive careful monitoring during and after treatment, with the total study duration extending over multiple years.

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