An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

To join this study, you generally need to be an adult aged 18 to 80. In some cases, young people aged 16 or 17 might be able to take part if their physical development is at a certain stage. You must have been diagnosed with moderately to severely active Crohn's disease for at least three months. This study is specifically for people whose current Crohn's treatments haven't worked well, have stopped working, or have caused difficult side effects.

There are also some reasons why you might not be able to join. For example, if you have Ulcerative Colitis, or if parts of your bowel have been extensively removed. If you have a history of certain specific gut conditions like high-grade dysplasia, or if you're taking other medications that might interfere with the study medicine, you wouldn't be eligible. Also, if you've previously taken similar experimental treatments for Crohn's disease, you wouldn't be able to participate.

If you decide to join this study, your journey could last up to 35 weeks (about 8 months). It starts with a screening period of up to 5 weeks to confirm you're suitable. After that, you'll enter one of the study's main treatment periods, which typically lasts 12 weeks. Some people may have an extended treatment period if needed.

During these periods, you'll receive either the study medicine, Duvakitug, or a placebo, and you won't know which one you're getting. You'll have regular visits to the clinic so the study team can monitor your health, check your symptoms, and see how you're responding to the treatment. These visits might involve physical examinations, blood tests, and discussions about your well-being. The number of scheduled visits will vary, depending on which part of the study you are in, potentially ranging from 8 to 15 visits. After your treatment period, there will be a follow-up period of about 6 weeks to ensure your health is stable.