This clinical trial is focused on studying Crohn’s disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The study is investigating the effects of a treatment called Risankizumab, which is a medication designed to help reduce inflammation and improve symptoms in patients with this disease. The medication is administered either as a solution for infusion, which means it is given directly into the bloodstream through a vein, or as a solution for injection using a pre-filled syringe, which is injected under the skin.

The purpose of this study is to evaluate how Risankizumab is processed in the body, its effectiveness, and its safety in children and teenagers aged 2 to under 18 years who have moderate to severe Crohn’s disease. The study will begin with an open-label phase, where all participants receive the medication, followed by a randomized double-blind phase, where participants will receive either the medication or a placebo without knowing which one they are getting. There will also be a long-term extension period to observe the effects over a longer time. Participants will be monitored for changes in their symptoms and any side effects they may experience.

The study is designed to last for several weeks, with regular check-ups and assessments to track the progress of the participants. The goal is to determine if Risankizumab can help achieve clinical remission, which means a significant reduction or disappearance of symptoms, and to see if it can lead to an endoscopic response, which is an improvement in the appearance of the digestive tract as seen through a camera. The study will also look at whether participants can achieve remission without the use of corticosteroids, which are often used to control inflammation but can have side effects when used long-term.