This clinical trial is focused on studying a condition known as ulcerative colitis, which is a chronic disease that causes inflammation and sores in the digestive tract, specifically affecting the innermost lining of the large intestine and rectum. The study is particularly interested in cases where the disease is moderately to severely active and has not responded well to standard treatments. The treatment being tested in this trial is a medication called Ozanimod, which is taken orally in the form of a hard capsule. Ozanimod is being evaluated for its effectiveness and safety in managing symptoms of ulcerative colitis in children who have not had success with other therapies.

The purpose of the study is to assess how well Ozanimod works in achieving clinical remission, which means reducing the symptoms of ulcerative colitis to a minimal level. Participants in the study will be randomly assigned to receive either Ozanimod or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. The study will take place over a period of time, with regular check-ups to monitor the participants’ health and the effects of the treatment. The goal is to see if Ozanimod can help reduce the inflammation and symptoms associated with ulcerative colitis, leading to an improved quality of life for those affected.

Throughout the study, various aspects of the participants’ health will be monitored, including the safety and tolerability of Ozanimod. This involves checking for any side effects or adverse reactions to the medication. The study will also look at how the body processes Ozanimod, which is known as pharmacokinetics, and how the drug affects the body, referred to as pharmacodynamics. By the end of the study, researchers hope to gather enough information to determine if Ozanimod is a viable treatment option for children with moderately to severely active ulcerative colitis.