Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

Investigating the safety, feasibility, and optimal dose of risankizumab-800CW for visualizing drug targeting in Inflammatory Bowel Disease

This early-stage study is exploring a new way to look at how a medicine called Skyrizi works in people who have Inflammatory Bowel Disease (IBD). Researchers want to find out if this special version of Skyrizi is safe, what the best dose is, and if it can help doctors see areas of inflammation more clearly inside the body. They will do this by giving a small amount of the special Skyrizi and then using special cameras and tests to see where it goes. The main goal is to check for any side effects and to see if the medicine can be visually tracked. This could help doctors understand how Skyrizi works to treat IBD.

At a glance

Status

Ongoing, recruiting

Phase

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

Sponsor

Universitair Medisch Centrum Groningen

Enrolment target

Start

05 Sep 2024

Inflammatory Bowel Disease (IBD)

What is this study about?

This study is focusing on Inflammatory Bowel Disease, or IBD, which includes conditions like Crohn's disease and ulcerative colitis. In IBD, parts of the digestive system become inflamed, causing various symptoms. Researchers are looking at a medicine called risankizumab-800CW, which is a special version of Skyrizi, a treatment already used for IBD.

The main idea behind this study is to see if this specially prepared Skyrizi can act like a tracer. This means that after a small amount is given, doctors want to see if it makes the inflamed areas in the bowel light up or show up more clearly when viewed with special cameras during procedures like an endoscopy. This could help them understand exactly where the medicine is going and how well it's working to target the inflammation.

Because this is an early-stage study (Phase I and II), the researchers are mostly interested in checking if this new approach is safe and finding the right amount (dose) to give. They will be carefully watching participants for any side effects. They'll also be using different methods, including special cameras and tests on small tissue samples, to see if they can visually track the medicine and find out if it's going to inflamed areas.

Key takeaways

This study is testing a special version of Skyrizi for IBD.
The main goals are to check safety and find the best dose.
Researchers want to see if the medicine can be visually tracked inside the body.
It's an early-stage study (Phase I and II) to gather important information.
Participation involves receiving the medicine and undergoing visual checks.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 years or older. This study is open to both men and women.

It's important to remember that there might be other specific health requirements or conditions that would make someone suitable or unsuitable for the study. These detailed criteria would be discussed with you by the study team.

If you have IBD and are interested, your doctor can help you understand if this study might be an option for you.

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?
Do you have Inflammatory Bowel Disease (IBD)?
Are you able to attend clinic visits for monitoring and assessments?
Are you willing to undergo procedures like endoscopy with biopsies?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive a special form of the Skyrizi medicine as an infusion. Before and after receiving the medicine, doctors and nurses will closely monitor your vital signs, like your heart rate and blood pressure, to ensure you are safe. They will also be looking out for any possible side effects or reactions.

The study involves several checks and tests. Doctors will use special cameras, often during an endoscopy, to look inside your bowel. They will be trying to see if the special medicine can be visualised and how much of it is in different areas. Small tissue samples (biopsies) might also be taken during these procedures to be looked at under a microscope in the lab.

There will be different visits to the clinic for these assessments, and the overall duration of your participation would be explained fully by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is helping researchers learn more about how IBD medicines work, which could lead to better treatments in the future. You might also receive careful medical monitoring. As for risks, there's always a chance of side effects from any new medication or procedure, though the study team will be carefully monitoring you. You would also undergo several medical procedures, each with its own small risks. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is Inflammatory Bowel Disease (IBD)?

IBD is a long-term condition where parts of your digestive system become inflamed, leading to symptoms like tummy pain, diarrhoea, and tiredness.

What is Skyrizi?

Skyrizi is a medicine used to treat certain inflammatory conditions, including some types of IBD. This study is using a special version of it.

Why are they calling it a 'tracer'?

A 'tracer' means they've made this Skyrizi special so that doctors can try to see where it goes in your body, almost like it's lighting up, to understand how it targets inflammation.

What does 'Phase I and II' mean?

These are early stages of a clinical trial. Phase I primarily checks if a treatment is safe, and Phase II looks at safety, how well it works, and the best dose.

Will this study cure my IBD?

This early-stage study is mainly focused on understanding how a new way of using medicine works and its safety, rather than providing a cure. While it might help your symptoms, the primary goal is research.