A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

To be considered for this study, you must be between 18 and 85 years old and have had symptoms of Crohn's disease for at least three months. Your Crohn's disease should be considered moderately to severely active, causing problems like frequent loose or watery stools or significant stomach pain. Also, you would typically have tried at least one other treatment for Crohn's disease (such as steroids, immunosuppressants like azathioprine, or biologic therapies) that either didn't work well enough, stopped working, or caused side effects you couldn't tolerate.

There are also some reasons why you wouldn't be able to join. For example, if you have other types of inflammatory bowel disease like ulcerative colitis, or if your Crohn's is only in specific small areas like your mouth or stomach and not in the main parts of your bowel. If you've had a lot of bowel surgery, have a condition called short bowel syndrome, or are currently using feeding tubes or special liquid diets, you might not be suitable. Certain serious health conditions, neurological problems, or if you've previously used a similar drug to MORF-057 would also prevent you from participating. You also can't be in another clinical trial at the same time or have recently received an experimental treatment.

If you decide to take part, you'll first go through a screening process to make sure the study is a good fit for you. If you qualify, the first part of the study lasts 14 weeks. During this time, you'll be randomly assigned to receive either MORF-057 (at one of three different doses) or a placebo (a dummy pill). Neither you nor your study team will know which you are receiving, which helps us get accurate results. For these 14 weeks, you'll have regular visits for check-ups, blood tests, and to discuss how you're feeling and any symptoms you might have.

After these 14 weeks, everyone in the study will then receive MORF-057 for a further 38 weeks. This is called the 'maintenance period'. If you complete this entire 52-week treatment period and wish to continue, you'll have the option to join a 'long-term extension' for another 52 weeks, where you would continue to receive MORF-057. Throughout these periods, there will be scheduled visits to monitor your health, how the medicine is working, and any side effects you might experience. The total time you could be in the study depends on whether you join the extension period.