Study Using Fluorescent Adalimumab and Risankizumab to See How These Drugs Work in Patients with Inflammatory Bowel Disease

This study is looking at Inflammatory Bowel Disease, which is a condition where the digestive tract becomes inflamed and causes symptoms like abdominal pain and diarrhea. The study will use two medications that are already approved for treating this condition: adalimumab and risankizumab. These medications will be modified by attaching special fluorescent dyes to them, which means they will glow under certain types of light. The adalimumab will be labeled with a dye called IRDye 680LT, and the risankizumab will be labeled with IRDye 800CW. The purpose of this study is to test whether a special imaging system called the Windu system can detect and see both of these glowing medications at the same time during an endoscopy, which is a procedure where a flexible tube with a camera is used to look inside the digestive tract.

During the study, patients who have active Inflammatory Bowel Disease and are eligible to receive either adalimumab or risankizumab as part of their treatment will undergo an endoscopy procedure. The fluorescently labeled medications will be given to patients before the endoscopy, and doctors will use special cameras and imaging equipment to see where these medications go in the digestive tract. The cameras can detect the glow from the dyes attached to the medications, allowing doctors to see exactly where the drugs are reaching in the inflamed areas. During the endoscopy, small tissue samples called biopsies will be taken from areas that show high and low amounts of glowing signal. These tissue samples will be examined in the laboratory using various techniques to measure how much of the medication is present and to understand how the medication is distributed in inflamed versus non-inflamed tissue.

The study will analyze the fluorescent signals both during the endoscopy procedure and afterward in the laboratory. Researchers will measure the strength of the glowing signals and compare them with how severe the inflammation is in different areas of the digestive tract. The tissue samples will be studied using microscopy and other laboratory methods to see which types of immune cells have taken up the medications and to measure the levels of specific proteins and genetic material related to inflammation. The study aims to understand whether this imaging technique can help visualize how these medications reach their targets in the body and whether the amount of fluorescent signal relates to the severity of inflammation and the response to treatment.