STENOVA - A Study to Evaluate Safety, Tolerability, PK and PD of AGMB-129 in Patients With Fibrostenotic Crohn's Disease

To be considered for this study, you need to be an adult (18 years or older) with a confirmed diagnosis of Crohn's disease for at least three months. You must have at least one narrowed section (stricture) in your lower small bowel or where your small and large bowel meet, which your doctor can see with an endoscope.

These strictures should be caused by Crohn's disease and confirmed by special scans. Also, you should be having symptoms like pain or cramping from these strictures but not so severe that you're expected to need immediate surgery or hospitalisation. You must be able to eat enough food, even if you've changed your diet, and you should be on stable Crohn's medication that you agree to continue throughout the study.

There are also reasons why you might not be able to join. For example, if you have other bowel conditions like ulcerative colitis, a history of extensive bowel surgery, or certain complications from Crohn's disease such as active abscesses or very severe inflammation. The study team will review your full medical history carefully to make sure it's safe for you to participate.

If you join this study, it will involve several visits to the clinic over a period of up to 19 weeks. First, there's a screening period of up to 5 weeks to check if you're suitable. This will include checks like a detailed bowel examination (ileocolonoscopy) and special scans (MRI of your bowel) to confirm the narrowed areas.

If you qualify, you'll be randomly assigned to one of three groups: receiving a high dose of AGMB-129, a low dose of AGMB-129, or a dummy treatment (placebo). Neither you nor your study doctor will know which treatment you are getting (this is called 'double-blind'). You'll receive this treatment for 12 weeks. During this time, you'll have blood tests, physical exams, vital sign checks, and ECGs. At the start and end of this 12-week period, you'll have another ileocolonoscopy with small tissue samples taken.

After these 12 weeks, there's a 2-week safety follow-up. Some participants who finish this part may have the option to continue receiving the treatment (AGMB-129) for up to an additional 48 weeks in an 'open-label' part, meaning everyone knows they are getting the active drug. There would be a final safety check 2 weeks after your last dose of treatment.