This clinical trial is focused on studying the effects of a medication called Upadacitinib in children with Crohn’s Disease, which is a condition that causes inflammation in the digestive tract. The study aims to evaluate how well this medication works, its safety, and how it behaves in the body. Participants in the study will receive Upadacitinib in different forms, such as oral solutions and tablets, over a period of time. The study will also involve a comparison with a placebo to understand the medication’s effectiveness better.
The trial is designed to help children who have not responded well to other treatments like corticosteroids, immunosuppressants, or biologic therapies. The study will begin with an open-label phase, where all participants receive Upadacitinib. This will be followed by a randomized, double-blind phase, where participants will either continue with the medication or receive a placebo without knowing which one they are taking. The study will also include a long-term extension phase where participants can continue to receive Upadacitinib.
The main goal of the study is to see if Upadacitinib can help achieve clinical remission, which means reducing the symptoms of Crohn’s Disease to a minimal level, and an endoscopic response, which involves healing of the digestive tract as seen through a special camera. The study will monitor participants for any side effects and measure their response to the treatment over time. This research is important for finding new ways to help children with Crohn’s Disease who have limited treatment options.



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