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Study on the Safety and Imaging of Risankizumab-800CW for Patients with Inflammatory Bowel Disease

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What is this study about?

This clinical trial is focused on studying Inflammatory Bowel Disease (IBD), which includes conditions like Crohn’s disease and ulcerative colitis. The study will use a treatment called risankizumab-800CW, a special form of the medication risankizumab, which is designed to help visualize how the drug targets the disease in the body. Risankizumab is a type of protein used to treat inflammation in the bowel. The purpose of the study is to evaluate the safety and effectiveness of this treatment in patients with IBD.

Participants in the study will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor the safety of the treatment by checking vital signs and observing any reactions at the injection site. Additionally, the study will use a technique called fluorescence molecular endoscopy (FME) to detect signals from the treatment, helping researchers determine the best dose for imaging. This involves using a special camera to see how the drug interacts with the body.

The study will also involve taking tissue samples to analyze the presence of the drug and its effects on the bowel. This will help researchers understand how the drug is distributed in inflamed and non-inflamed tissues. The study aims to find a correlation between the drug’s presence and the level of inflammation, providing insights into how well the treatment works in targeting the disease. The trial is expected to continue until October 2025.

1 joining the study

Upon joining the study, the patient must have a confirmed diagnosis of Inflammatory Bowel Disease (IBD), which includes conditions like ulcerative colitis (UC) or Crohn’s disease (CD).

The patient must be at least 18 years old and provide written informed consent.

A negative pregnancy test is required for female patients of childbearing potential.

2 initial assessment

The patient undergoes an initial assessment to confirm active disease, which may involve clinical evaluation and biochemical tests.

Eligibility for risankizumab therapy is confirmed during this stage.

3 medication administration

The patient receives Skyrizi 600 mg as a solution for infusion. This medication is administered through an intravenous infusion.

The purpose of this medication is to evaluate its safety and to visualize drug targeting in the body.

4 monitoring and evaluation

Vital signs are monitored before and after the administration of the medication to ensure safety.

The patient is observed for any adverse events, which are unexpected reactions to the medication.

5 endoscopic procedure

A fluorescence molecular endoscopy (FME) is performed to detect signals from the medication.

This procedure helps in determining the optimal imaging dose of the medication.

6 data analysis

Fluorescence signals are analyzed and compared to inflammation scores obtained from endoscopic and histological evaluations.

The analysis helps in understanding the distribution of the medication in inflamed and non-inflamed tissues.

7 follow-up

The patient may undergo additional follow-up assessments to monitor the long-term effects of the medication.

The study is estimated to conclude by October 20, 2025.

Who Can Join the Study?

  • Must have a confirmed diagnosis of Inflammatory Bowel Disease (IBD), which includes conditions like Ulcerative Colitis (UC) or Crohn’s Disease (CD).
  • Must have active disease, meaning the bowel is showing signs of activity. This can be determined by specific scoring methods or by a test showing a fecal calprotectin level greater than 60 micrograms per gram. Fecal calprotectin is a substance found in stool that indicates inflammation in the intestines.
  • Must be eligible to receive a medication called risankizumab.
  • Must be at least 18 years old.
  • Must provide written informed consent, which means agreeing to participate in the study after understanding all the details.
  • Must have a medical reason to undergo an endoscopic procedure, which is a test that allows doctors to look inside the digestive tract using a special camera.
  • If a female participant is of childbearing potential, meaning she can still have children, she must have a negative pregnancy test. This applies to women who are premenopausal with intact reproductive organs or less than 2 years postmenopausal.

Who Cannot Join the Study?

Where you can join this trial?

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Other Sites

Site Name City Country Status
Umgosdfffife Mcwasto Cmgttpa Gisclkooi 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
Not recruiting
21.10.2024

Trial locations

Investigated drugs:

Risankizumab-800CW is a medication being studied for its ability to help visualize drug targeting in patients with Inflammatory Bowel Disease. The trial aims to assess the safety of this medication by monitoring vital signs and the injection site, as well as evaluating any potential adverse events related to the tracer. Additionally, the study investigates the feasibility of using special imaging techniques to detect signals from risankizumab-800CW and determine the best dose for imaging purposes.

Investigated diseases:

Inflammatory Bowel Disease (IBD) – This is a term used to describe disorders that involve chronic inflammation of the digestive tract. The two main types of IBD are Crohn’s disease and ulcerative colitis. Crohn’s disease can affect any part of the gastrointestinal tract from the mouth to the anus, while ulcerative colitis primarily affects the colon and rectum. Symptoms often include persistent diarrhea, abdominal pain, rectal bleeding, weight loss, and fatigue. The inflammation can lead to complications such as strictures, fistulas, and increased risk of colon cancer. The exact cause of IBD is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors.

Trial ID:
2024-515358-25-00
Protocol code:
20010
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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