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

To be considered for this study, young people generally need to be between 6 and 17 years old and have had severe alopecia areata for at least a year. Their current hair loss episode should have lasted for at least six months, and a specific measure of hair loss, called a SALT score, needs to be 50% or higher. This score helps doctors understand how much hair loss there is. Participants should also have tried at least one other treatment for their alopecia that didn't work.

There are also reasons why someone might not be able to join. For example, if they have certain other health conditions, such as other types of hair loss, untreated high blood pressure, or serious heart, liver, or kidney problems. The study also cannot include individuals who have been largely unable to care for themselves or have had major surgery recently. It's important that participants don't have certain infections like active hepatitis B or C.

If you decide to take part, the study will involve several stages over a long period. First, there's a 5-week 'Screening' period where doctors will do tests to see if you're suitable for the study. If you are, you'll then enter a 'Double-Blind Treatment Period' lasting for 36 weeks. During this time, you'll be given either the study medicine (baricitinib) or a placebo, but neither you nor your doctor will know which one you're receiving.

After this, there's an 'approximately 2-year Long-Term Extension' period where all participants who continue in the study will likely receive the active medicine. Finally, there's a 4-week 'Post-treatment Follow-up' to check on your health after the main treatment ends. Some participants might even be able to continue receiving treatment for even longer, up to a total of 180 weeks. Throughout the study, you'll have regular visits to the clinic for check-ups, blood tests, and to see how your hair is responding.