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 trial is specifically looking at children with moderately to severely active Crohn’s Disease. The treatment being tested is called Guselkumab, which is a type of medication known as a monoclonal antibody. Monoclonal antibodies are proteins made in a lab that can bind to substances in the body, including cancer cells, and are used to treat various diseases. In this study, Guselkumab is given as an injection under the skin or as an infusion into a vein.

The purpose of the study is to evaluate how effective and safe Guselkumab is for children with Crohn’s Disease. Participants in the study will receive either Guselkumab or a placebo, which looks like the treatment but does not contain the active medicine. The study will last for about a year, during which participants will have regular check-ups to monitor their health and the effects of the treatment. The main goal is to see if the participants achieve clinical remission, meaning their symptoms improve significantly, and to check for any changes in the inflammation of the digestive tract.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to gather information on how well the treatment works. The study aims to provide valuable insights into the potential benefits of Guselkumab for treating Crohn’s Disease in children, which could lead to better treatment options in the future.