A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease

To be considered for this study, your child must have been diagnosed with Crohn's disease, including specific types like active colitis or ileocolitis. Their Crohn's disease must also be considered moderately to severely active when they join the study, as shown by certain medical scores and an endoscopy (a procedure to look inside the digestive system) within one month of starting the medicine.

It's also important that your child has already tried and not responded well to, or couldn't tolerate, at least one other treatment for Crohn's disease. This could include medicines like immunomodulators, steroids, certain biologic therapies, or JAK inhibitors.

However, your child cannot join the study if they have certain complications of Crohn's, such as narrowings in the bowel that cause problems, or if they've recently had surgery on their bowel or tummy. They also cannot have any abscesses (pockets of infection) at the time of screening. The study is open to both boys and girls aged between 2 and 17 years.

If your child takes part in this study, they would be carefully checked to make sure they are suitable. Then, they would be randomly assigned to receive either mirikizumab or another treatment. This is like flipping a coin to decide, making sure the comparison between the treatments is fair.

The study starts with a 12-week 'induction period' where the medicine aims to bring symptoms under control. After this, there's a 'maintenance period' lasting until week 52, where the medicine helps keep symptoms settled. Finally, there's a safety follow-up period for up to 16 weeks to ensure everything is okay. In total, the study will last about 74 weeks (around 1 year and 5 months) and could involve up to 19 visits to the clinic for check-ups and assessments. These visits will help the doctors monitor your child's health and how the medicine is working.