A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease
This study is investigating a new medicine called zasocitinib for adults who have active Crohn's disease. Crohn's is a long-term condition that causes inflammation and sores in the gut. The main goals are to find out exactly how zasocitinib works inside the body to help with Crohn's and to check how safe it is. Participants will take the medicine for 3 months. During this time, they will have several clinic visits and a special test called an ileocolonoscopy, where a doctor looks inside the bowel with a small camera. This helps researchers see the medicine's effect on the disease directly. The study is for a small number of people and lasts about 5 months in total.
At a glance
What is this study about?
Crohn's disease is a serious, ongoing condition that can cause swelling and painful sores anywhere in your digestive system, from your mouth to your bottom. This often leads to symptoms like tummy pain, diarrhoea, and tiredness. For many people, existing treatments don't always work as well as hoped, or they can't tolerate them.
This study is looking at a new medicine called zasocitinib. We want to understand how this medicine affects Crohn's disease at a very detailed level, looking at cells and tiny molecules in your body. We also want to check how safe this new treatment is for people with Crohn's. The information gathered will help us learn more about potential new ways to treat this condition.
Taking part would mean you receive zasocitinib for 12 weeks (3 months). Over this period, and for a short time afterwards, you would have several appointments at the study clinic. These appointments will involve tests to see how the medicine is working and to keep a close eye on your health. This is a small study involving about 20 people and is taking place at one location, helping us gather important early information.
Key takeaways
- This study is testing a new medicine called zasocitinib for Crohn's disease.
- It aims to understand how the medicine works and if it's safe.
- Participation involves taking the medicine for 3 months and having regular check-ups.
- A camera test of your bowel (ileocolonoscopy) is a key part of the study.
- The study lasts about 5 months in total, including follow-up.
Who may be eligible?
This study is looking for adults aged between 18 and 75 years old who have been diagnosed with Crohn's disease for at least one month. To be considered, you should have tried other Crohn's treatments before, but these treatments either stopped working for you or caused side effects that you couldn't manage.
There are also some important reasons why you might not be able to join. For example, if you have other conditions causing bowel inflammation, or if your Crohn's disease currently has complications that might need surgery soon. You also can't take part if you have active infections, or have recently had surgery on your belly or bowel.
The study team will discuss all the detailed requirements with you to make sure it's the right fit. It's important that you are able to have blood samples taken and tolerate a camera test of your bowel.
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 between 18 and 75 years old?
- Have you been diagnosed with Crohn's disease for at least one month?
- Have you tried other Crohn's treatments that are no longer working or you can't tolerate?
- Do you not have other serious bowel conditions or complications needing surgery soon?
- Are you able to have blood taken and a bowel camera test?
What does participation involve?
If you join this study, you will take the medicine called zasocitinib for 3 months (12 weeks). During this time, and for a short safety check afterwards, the study will last about 5 months in total. You'll need to visit the study clinic several times for appointments.
At these visits, the doctors and nurses will carry out tests to see how the medicine is affecting your Crohn's and to monitor your health carefully. This includes giving blood samples and having a special test called an ileocolonoscopy. This is where a doctor uses a thin, flexible tube with a tiny camera to look inside your large bowel and the end of your small bowel. This test will be done before you start the medicine and again during the study to see how your bowel has changed. You'll also be asked questions about your symptoms and how you're feeling.
Potential risks and benefits
Locations (1)
- Oxford Experimental Medicine Clinical Research FacilityVerified postcodeOxford, United Kingdom· Recruiting
Common questions
What is zasocitinib?
Zasocitinib is a new medicine being tested for Crohn's disease. Researchers want to understand how it works and check its safety.
How long will I take the medicine for?
You will take the medicine for 3 months (12 weeks) as part of the study.
What is an ileocolonoscopy?
This is a test where a doctor uses a small camera on a flexible tube to look inside your bowel. It helps them see how the medicine is affecting your Crohn's.
How many times will I visit the clinic?
You will need to visit the study clinic several times during the 5-month study period for checks and tests.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason, and it won't affect your ongoing medical care.
How to find out more
Takeda Contact
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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