Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease

This study is looking for children and teenagers aged 2 to 17 years old who have Crohn's disease that is moderately to severely active. This means their Crohn's is causing significant problems, and previous treatments like steroids, other strong medicines, or biologic therapies haven't worked well enough, have stopped working, or caused bad side effects. You must weigh at least 10 kg (about 22 pounds) to join.

To be considered, your child's Crohn's disease must be confirmed by a colonoscopy (an examination of the bowel) and show signs of inflammation. We need to make sure there are no other infections, growths, or serious complications of Crohn's that would prevent participation.

There are also some reasons why someone might not be able to join. For example, if they were diagnosed with Crohn's before they were 2 years old, or if they have certain complications like active abscesses (pus-filled pockets), severe narrowing of the bowel, or have had recent bowel surgery. Also, if they have other types of inflammatory bowel disease like ulcerative colitis, they wouldn't be able to participate in this study.

If you join this study, your child will take Upadacitinib as a tablet once a day or a liquid medicine twice a day, usually around the same time each day, with or without food. The study is divided into two main parts. For the first 12 weeks, everyone knows they are getting an active dose of the medicine. After that, for about a year, it's a 'blinded' phase, meaning neither you nor the study doctors will know which dose of the medicine your child is receiving. This helps make the study results fair and unbiased. There's also an optional long-term extension of up to three more years where everyone knows they are getting the medicine.

Throughout the study, your child will have regular visits to a hospital or clinic, which could be weekly or monthly, especially at the beginning. During these visits, the medical team will check their health, take blood samples, and ask about any side effects. Your child will also complete questionnaires to help understand how they are feeling. These visits help the doctors monitor how the medicine is working and keep your child safe. After stopping the study medicine, there will be one final safety check approximately 30 days later. The total time a child could be in the study is several years if they participate in all phases.