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.
Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.
Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.
Eli Lilly and Company (LLY) is the sponsoring company for this trial. BiotechSign currently grades this company C (54/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.