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

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What is this study about?

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.

1 Receiving the first medication

You will receive one of two medications as part of this trial: either risankizumab or adalimumab. These medications are used to treat inflammatory bowel disease.

If you receive risankizumab, it will be given as an infusion, which means the medication will be delivered directly into your vein through a needle.

If you receive adalimumab, it will be given as an injection under the skin using a pre-filled syringe.

The medication you receive will be labeled with a special fluorescent marker that allows doctors to see where the medication goes in your body during the examination.

2 Undergoing endoscopic examination

You will undergo an endoscopic procedure, which is an examination where a thin tube with a camera is inserted into your digestive tract to look at the inside of your bowel.

During this procedure, a special imaging system called the Windu system will be used to detect the fluorescent signals from the labeled medication in your bowel tissue.

The examination will allow doctors to see where the medication is located in areas of inflammation and in areas without inflammation.

During the endoscopy, measurements will be taken using spectroscopy, a technique that analyzes the fluorescent light signals in real time.

3 Collection of tissue samples

During the endoscopy, small tissue samples (biopsies) will be taken from your bowel.

These samples will be collected from areas that show high fluorescent signals and from areas that show low fluorescent signals.

The tissue samples will be used for further analysis to measure the amount of fluorescent medication present and to examine the inflammation level.

4 Blood sample collection

A blood sample will be collected from you.

This blood sample will be used to check the integrity of the labeled medication in your bloodstream and to perform additional laboratory tests.

5 Laboratory analysis of samples

The tissue samples collected during the endoscopy will be analyzed using various laboratory techniques.

The samples will be examined under a fluorescence microscope to see the distribution of the labeled medication at a microscopic level.

Additional tests will be performed to identify the types of immune cells that contain the labeled medication.

The samples will also be tested to measure the levels of specific proteins and genetic material related to inflammation.

These analyses will help determine how the medication distributes in inflamed and non-inflamed tissue and how it relates to the severity of inflammation.

Who Can Join the Study?

  • You must have a confirmed diagnosis of Inflammatory Bowel Disease, which means long-term inflammation in your digestive tract, either Ulcerative Colitis or Crohn’s Disease
  • You must have active disease, meaning your condition is currently causing symptoms or showing signs of inflammation, determined by either clinical scoring methods or by a stool test called fecal calprotectin showing a level higher than 60 micrograms per gram
  • You must be suitable to receive treatment with medications called adalimumab or risankizumab, which are drugs used to reduce inflammation in the bowel
  • You must be at least 18 years old
  • You must provide written permission to participate in the study after understanding all the information
  • You must have a medical reason to undergo an endoscopic procedure, which is an examination where a thin tube with a camera is used to look inside your digestive tract
  • If you are a woman who can become pregnant, meaning you still have menstrual periods or have not gone through menopause for at least 2 years, you must have a negative pregnancy test using either urine or blood

Who Cannot Join the Study?

  • No specific exclusion criteria (reasons why you cannot join the study) have been provided for this clinical trial at this time.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Ugfeyvrtkdav Mqfpvwh Cpjoemv Gjayjssej Groningen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
01.01.2026

Trial locations

Investigated drugs:

Adalimumab is a medication used to treat inflammatory bowel diseases by reducing inflammation in the digestive tract. In this study, it is labeled with a fluorescent marker so doctors can see where the medication goes in your body using special imaging equipment.

Risankizumab is a medication that works by blocking certain proteins that cause inflammation in inflammatory bowel diseases. In this study, it is also labeled with a fluorescent marker to help doctors track and visualize where the medication travels and attaches in your digestive system.

Investigated diseases:

Inflammatory Bowel Disease – Inflammatory Bowel Disease is a group of chronic conditions that cause inflammation in the digestive tract. The disease involves the immune system mistakenly attacking the lining of the intestines, leading to ongoing inflammation. Patients experience periods of active disease with symptoms such as abdominal pain, diarrhea, and rectal bleeding, alternating with periods of remission when symptoms improve or disappear. The inflammation can affect different parts of the digestive system depending on the specific type of the disease. Over time, repeated inflammation may lead to complications such as narrowing of the intestines or the formation of abnormal connections between different parts of the bowel. The condition typically requires long-term management as it tends to be a lifelong disorder with fluctuating severity.

Trial ID:
2025-521420-30-00
Protocol code:
21773
Trial Phase:
Human Pharmacology (Phase I) – Other

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