Study on the Safety and Imaging of Adalimumab-680LT 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 treatment being investigated is a medication called Adalimumab-680LT, which is a version of the drug Humira. This study aims to explore the safety and effectiveness of using a special form of Adalimumab that is labeled with a fluorescent dye to help visualize how the drug targets the disease in the body.

The purpose of the study is to evaluate the safety of Adalimumab-680LT by monitoring participants’ vital signs and checking for any adverse reactions after the drug is administered. Additionally, the study will investigate how well a technique called fluorescence molecular endoscopy can detect the drug in the body. This involves using a special camera to see the fluorescent signals from the drug, which helps determine the best dose for imaging purposes.

Participants in the study will receive injections of Adalimumab-680LT and will undergo various imaging procedures to observe how the drug behaves in the body. The study will also compare images and tissue samples taken before and after at least 14 weeks of treatment to understand how the drug affects inflamed and non-inflamed tissues. This research will provide insights into the presence of immune cells and the stability of the drug within the body, contributing to a better understanding of its potential benefits for treating IBD.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This confirms your understanding and agreement to participate in the clinical trial.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying your diagnosis of inflammatory bowel disease (IBD) and ensuring you meet other criteria such as age and clinical indications for an endoscopic procedure.

3 medication administration

You will receive the medication adalimumab-680LT, which is a fluorescently labeled version of adalimumab. The medication is administered as a subcutaneous injection, meaning it is injected under the skin.

The dosage and frequency of administration will be determined by the study team based on the optimal imaging dose required for the trial.

4 monitoring and evaluation

Your vital signs will be monitored before and after the administration of the medication to ensure your safety. This includes checking for any adverse reactions at the injection site or elsewhere.

You will undergo fluorescence molecular endoscopy (FME) to visualize the drug targeting within your body. This procedure helps in detecting the signals from the medication.

5 follow-up assessments

Follow-up assessments will be conducted to compare the results of the fluorescence images and other measurements before and after at least 14 weeks of treatment.

These assessments may include additional imaging, biopsies, and other tests to evaluate the presence of the medication in your tissues and its effects on inflammation.

6 end of participation

Your participation in the study will conclude after the final assessments are completed. The estimated end date for the trial is December 31, 2024.

Who Can Join the Study?

Have a confirmed diagnosis of Inflammatory Bowel Disease (IBD), which includes conditions like Ulcerative Colitis (UC) or Crohn’s Disease (CD).
Have active disease, meaning the bowel disease is currently showing symptoms. This is determined by specific scoring systems and a test result showing a fecal calprotectin level greater than 60 µg/g within the last 6 weeks.
Be eligible to receive treatment with a medication called adalimumab.
Be at least 18 years old.
Provide written informed consent, which means you agree to participate in the study after understanding all the details.
Have a medical reason to undergo an endoscopic procedure, which is a test that allows doctors to look inside your digestive tract.

Who Cannot Join the Study?

Patients with Inflammatory Bowel Disease (IBD) cannot participate. This is a condition where parts of the digestive system become inflamed.
Patients who have experienced severe allergic reactions to similar medications in the past are not eligible.
Individuals with active infections, which means infections that are currently causing symptoms, cannot join the study.
Patients who are pregnant or breastfeeding are excluded from participating.
Anyone who has participated in another clinical trial within the last 30 days is not allowed to join.
Patients with a history of cancer, except for certain types of skin cancer, are not eligible.
Individuals with significant heart, liver, or kidney problems cannot participate.
Patients who have received certain vaccines within the last 4 weeks are excluded.
Anyone with a history of drug or alcohol abuse in the past year is not eligible.
Patients who are unable to comply with the study procedures, which means they cannot follow the study instructions, are excluded.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Uwaqxtdysazs Mdcrwbt Chunesb Gkcdwlnaq	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.02.2024

Trial locations

Investigated drugs:

Adalimumab

Adalimumab-680LT is a special version of a medication called adalimumab, which is commonly used to treat inflammatory conditions like Inflammatory Bowel Diseases (IBD). In this clinical trial, the medication has been labeled with a fluorescent marker, which means it can glow under certain lights. This helps doctors see where the medication goes in the body and how it targets the inflammation. The main goal of using this fluorescently labeled medication is to make it easier for doctors to visualize and understand how well the drug is working in treating the inflammation associated with IBD.

Investigated diseases:

Inflammatory bowel disease

Inflammatory Bowel Disease (IBD) – Inflammatory Bowel Disease is a chronic condition characterized by inflammation of the gastrointestinal tract. It primarily includes two main types: Crohn’s disease and ulcerative colitis. The inflammation can cause symptoms such as abdominal pain, diarrhea, and weight loss. Over time, the inflammation can lead to damage of the intestinal walls, resulting in complications like strictures or fistulas. The disease often progresses with periods of flare-ups and remissions. The exact cause of IBD is not fully understood, but it involves an abnormal immune response to intestinal bacteria.

Trial ID:

2023-508391-11-00

Protocol code:

18146

NCT ID:

NCT06117423

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on the Safety and Imaging of Adalimumab-680LT for Patients with Inflammatory Bowel Disease

What is this study about?

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Who Cannot Join the Study?