Investigating the safety, feasibility, and optimal dose of fluorescently labeled Adalimumab-680LT for visualizing drug targeting in Inflammatory Bowel Diseases.
This study is investigating a new approach to understand how a common medicine called adalimumab (also known as Humira) works in people living with Inflammatory Bowel Disease (IBD). Researchers have created a special version of adalimumab that has a fluorescent tag, meaning it glows, and they want to see if they can safely track it inside the body. The main goal is to figure out the best dose and to see if this glowing medicine can help doctors literally 'see' where the drug goes and how it targets the inflamed areas. This will help them understand the drug's effects and how it impacts the disease. It's an early-stage study, focusing on safety and whether this new method is practical.
At a glance
What is this study about?
This study is about understanding how a medicine called adalimumab, often known by its brand name Humira, works in people with Inflammatory Bowel Disease (IBD). IBD includes conditions like Crohn's disease and ulcerative colitis, where the gut becomes inflamed. Adalimumab is a common treatment for these conditions, and it works by targeting specific parts of the immune system that cause inflammation.
In this research, scientists have made a special version of adalimumab that has a tiny 'glow' to it. Think of it like adding a miniature light to the medicine. The idea is that by making the medicine glow, doctors might be able to see exactly where it's going in the body and how it's affecting the inflamed areas in the gut. This could give them very valuable information about how the drug works and potentially how to make treatments even better in the future.
This is an early-stage study, called Phase 1 and 2. This means the main goals are to make sure that this special glowing version of adalimumab is safe to use in people and to find the best dose. They'll be watching participants very closely for any side effects and seeing if they can clearly "see" the drug at work. This kind of research is important because it helps us learn more about how treatments work at a very detailed level, which can lead to improved ways to manage IBD.
Key takeaways
- This study is testing a special version of an IBD medicine that glows.
- It aims to see where the medicine goes and how it works in the body.
- The main goals are to check safety and find the best dose.
- It's for adults with Inflammatory Bowel Disease.
- Participation involves injections, closely monitored safety checks, and some imaging/biopsy procedures.
Who may be eligible?
To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
Because this is an early study, there will be other specific health requirements to make sure it's safe for you to take part. For example, you would typically need to have a confirmed diagnosis of Inflammatory Bowel Disease and meet certain medical criteria related to your overall health and any other medications you might be taking. The study team will review all your medical information carefully to see if you are a good fit.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with Inflammatory Bowel Disease (IBD)?
- Are you able to attend clinic visits and follow study instructions?
- Are you generally in good health, apart from your IBD?
What does participation involve?
If you decide to take part, you will be given the special glowing adalimumab medicine as an injection. The research team will regularly check your vital signs, like your heart rate and blood pressure, both before and after you receive the medicine, to make sure you are safe. They will also be very carefully looking for any possible side effects.
During the study, doctors will use special cameras to take pictures to see where the glowing medicine goes in your body. They might also take small tissue samples (biopsies) from your gut. These samples will be examined under special microscopes to see how much of the glowing medicine is present and how it's affecting the cells. You will have these assessments at certain times, including before and after about 14 weeks of treatment with the glowing medicine. The total duration of your involvement in the study will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is Inflammatory Bowel Disease (IBD)?
IBD is a group of conditions that cause long-lasting inflammation in your digestive system, like Crohn's disease and ulcerative colitis. It's different from Irritable Bowel Syndrome (IBS).
What is adalimumab (Humira)?
Adalimumab is a common medicine used to treat IBD. It works by calming down parts of your immune system that cause inflammation.
Why does the medicine 'glow' in this study?
The glowing tag helps doctors see exactly where the medicine goes in your body and how it affects the inflamed areas. This helps them understand how the treatment works better.
Is this a new medicine?
The adalimumab medicine itself is already approved and used. This study is testing a special version with a tiny 'glow' to gain new insights into its effects.
Will I still get my usual IBD care if I join?
Yes, your right to receive your usual medical care will not be affected if you choose to participate in or withdraw from the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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