This clinical trial is focused on studying the treatment of Crohn’s Disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain and diarrhea. The study will evaluate the effectiveness and safety of a combination treatment using two medications: Vedolizumab, which is given through an intravenous infusion, and Upadacitinib, taken as an oral tablet. Vedolizumab is known by the brand name Entyvio, and Upadacitinib is known as Rinvoq. The trial will compare the results of using both medications together against using Vedolizumab with a placebo, which looks like the medication but does not contain the active drug.

The purpose of the study is to see if the combination of Vedolizumab and Upadacitinib can improve the health of people with moderately to severely active Crohn’s Disease more effectively than Vedolizumab alone. Participants will receive the treatment for a period of up to 52 weeks. Initially, both medications will be used together for a short period to see if they can quickly improve symptoms and the condition of the digestive tract. After this initial phase, the study will continue with Vedolizumab alone to maintain the improvements.

Throughout the study, participants will be monitored to assess their response to the treatment, focusing on both clinical symptoms and the condition of the digestive tract as seen through medical examinations. The study aims to provide valuable information on whether this dual therapy approach can offer better outcomes for individuals living with Crohn’s Disease.