RecruitingPhase 1Phase 2NCT06117423

Fluorescence Imaging of Adalimumab-680LT in Inflammatory Bowel Disease

Investigating the Safety, Feasibility, and Optimal Dose of Fluorescently Labeled Adalimumab-680LT for Visualizing Drug Targeting in Inflammatory Bowel Diseases


Sponsor

University Medical Center Groningen

Enrollment

21 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Crohn's Disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases (IBD). Adalimumab is a human monoclonal antibody against TNF-alpha, a pro-inflammatory cytokine that mediates the inflammatory response in IBD upon binding to the TNF receptors. Primary non-response to adalimumab is high in both CD and UC. Currently, there are no predictors of response to adalimumab and the actual mechanism of action has not yet been elucidated. To gain better understanding of the drug targeting of adalimumab in IBD, the University Medical Center Groningen (UMCG) developed fluorescently labeled adalimumab (adalimumab-680LT). This study aims to assess the safety and the optimal dose of adalimumab-680LT to visualize and potentially quantify the local drug concentration and predict treatment response in IBD patients using in vivo and ex vivo fluorescence molecular imaging (FMI).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a specially tagged form of adalimumab (a drug used to treat inflammatory bowel disease) that glows under special imaging light. During an endoscopy, doctors can see exactly where the drug is binding in the gut lining — helping to predict whether a patient will respond to adalimumab therapy before committing to full treatment. **You may be eligible if:** - You have confirmed inflammatory bowel disease (Crohn's disease or ulcerative colitis) - Your disease is currently active (at least mildly) - You are eligible to start adalimumab therapy - You have a clinical reason to undergo an endoscopic procedure - You are 18 or older - You have a negative pregnancy test if applicable **You may NOT be eligible if:** - You have previously received adalimumab or other anti-TNF treatments - You have active serious infections or other major health conditions - You are pregnant or breastfeeding - You have a known allergy to adalimumab Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdalimumab-680LT

First, adalimumab-680LT was administered intravenously. 2-3 days later, a Fluorescence Molecular Imaging procedure was performed to enable the visualisation and detection of fluorescence signals.

OTHERControl

Fluorescence Molecular Imaging was performed to enable the visualisation and detection of fluorescence signals.


Locations(1)

University Medical Center Groningen

Groningen, Netherlands

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NCT06117423


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