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 compares two treatments: Risankizumab and Ustekinumab. Both medications are proteins used to reduce inflammation and are administered as injections. Risankizumab is given either as a solution for injection in a pre-filled syringe or as a solution for infusion, while Ustekinumab is available as a solution for injection or infusion as well.
The purpose of the study is to evaluate the effectiveness and safety of Risankizumab compared to Ustekinumab in adults with moderate to severe Crohn’s Disease who have not responded well to previous treatments known as anti-TNF therapies. The study is divided into two parts. In the first part, participants will receive either Risankizumab or Ustekinumab for 48 weeks. The second part will focus on the long-term safety of Risankizumab for up to 220 weeks for those who completed the first part. There is also a Continuous Treatment Extension to ensure ongoing care with Risankizumab until it becomes commercially available or participants can access it locally.
Participants will be monitored for clinical remission, which means a significant reduction in symptoms, and endoscopic remission, which involves healing of the digestive tract as seen through a camera. The study aims to determine if Risankizumab is as effective or more effective than Ustekinumab in achieving these outcomes. The trial will also assess the ability to maintain remission without the use of steroids, which are often used to control inflammation. The study is expected to continue until 2027.
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