A phase IIa, open label, Single-centre study to assess the initial antifibrotic efficacy, safety, tolerability, pharmacokinetic and pharmacodynamic profile of MBF-118 in Crohn’s disease patients with stenosis.
This study is looking into a new medicine called MBF-118 for people with Crohn's disease who have a specific problem: their gut has become narrowed, a condition called stenosis. Researchers want to understand if MBF-118 is safe to use and how well people tolerate it. They will also be checking if the medicine can help reduce the gut narrowing and inflammation, which are common issues in Crohn's. The study will involve giving the medicine for 28 days and then observing patients for another 28 days to see its effects. This is an early-stage study, meaning it's one of the first times this medicine is being tested in a small group of patients to learn more about it.
At a glance
What is this study about?
This study is focused on people living with Crohn's disease, specifically those who have developed a common complication called stenosis. Stenosis means that parts of the bowel have become too narrow, which can cause blockages and other problems. The researchers are studying a new medicine, MBF-118, to see if it can help with this issue. This is an exploratory study, which means it’s an early step in understanding how this medicine works, how safe it is, and if it could potentially be a future treatment option.
The main goal of this study is to check the safety of MBF-118 and how well people can tolerate it. This involves carefully looking for any side effects and monitoring general health. Beyond safety, the study also aims to see if the medicine has any positive effects on the narrowed parts of the bowel. They will measure things like the thickness of the bowel wall and levels of inflammation markers in the blood and stool to see if the medicine makes a difference.
In simpler terms, think of it like this: if your gut is like a hose, and parts of it are getting squeezed shut, this medicine is being tested to see if it can help open it up a bit or stop it from getting worse. It's a key step in developing new treatments for Crohn's disease that could improve life for many patients.
Key takeaways
- This study is for people with Crohn's disease and bowel narrowing (stenosis).
- It's testing a new medicine called MBF-118.
- The main goals are to check the medicine's safety and how well people tolerate it.
- They will also look for signs the medicine helps reduce narrowing and inflammation.
- Participation involves taking the medicine for 28 days and follow-up for 28 more days.
- You can stop participating at any time if you wish.
Who may be eligible?
To join this study, participants must be at least 18 years old, and there is no upper age limit. The study is open to both men and women.
More specific details about who can and cannot take part will be provided by the study team. These rules are in place to make sure the study is safe for everyone involved and that the results are clear and reliable. For example, people might not be able to join if they have other serious health problems or are taking certain medications.
If you're interested, the study team will ask you questions about your health and medical history to confirm if you meet all the requirements.
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 a diagnosis of Crohn's disease?
- Do you have bowel narrowing (stenosis) related to your Crohn's?
- Are you able to attend regular appointments at the study centre?
- Are you generally able to take new medicines as prescribed?
What does participation involve?
If you decide to take part, you would receive the study medicine, MBF-118, for a period of 28 days. During this time and for another 28 days afterwards (making a total of 56 days), you would have regular visits to the study centre. These visits are important for the team to monitor your health and how the medicine is affecting you.
During these visits, assessments would include physical examinations, checking your vital signs (like blood pressure and heart rate), taking blood and stool samples for laboratory tests, and possibly having heart tracings (ECGs). They would also measure the thickness of your bowel walls to see if the medicine is having an effect on the narrowing. You will be asked about any side effects you experience. The total duration of active involvement in the study would be approximately 56 days.
Potential risks and benefits
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Common questions
What is 'stenosis' in Crohn's disease?
Stenosis means a part of your bowel has become abnormally narrow, which can cause problems like blockages.
Is MBF-118 a new medicine?
Yes, MBF-118 is a new medicine being tested. This study is an early stage of research to learn about it.
How long will I take the medicine for?
You would take the study medicine for 28 days.
What kind of tests will I have?
You will have physical exams, blood tests, stool tests, vital sign checks, and possibly heart tracings (ECGs) and bowel imaging.
Can I stop participating if I want to?
Yes, you are free to leave the study at any time without giving a reason, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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