A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis
Ulcerative colitis is an ongoing condition that causes swelling and ulcers in the bowel. This research study looks at a tablet called filgotinib (brand name Jyseleca) to see if it remains safe and helpful when taken over a longer period. The trial is open to adults aged 18 and over who have ulcerative colitis. Researchers want to make sure the medicine does not cause unexpected side effects with long-term use. During the study, doctors will keep a close eye on participants through regular clinic visits, physical checks, and blood tests. They will also track gut symptoms, such as stomach pain and how often people need to use the toilet. Taking part helps doctors learn if this tablet can offer safe, lasting relief for people living with ulcerative colitis.
At a glance
What is this study about?
Ulcerative colitis is a long-term gut condition where parts of the bowel become swollen and inflamed. This can cause troublesome symptoms like frequent diarrhoea, bleeding, stomach cramps, and extreme tiredness. Finding treatments that keep symptoms under control for many months or years is an important goal for doctors and patients alike.
This study focuses on a medicine called filgotinib, also known by its brand name Jyseleca. Filgotinib comes as a daily tablet and works by calming down the overactive parts of the body's immune system that cause gut swelling. While earlier tests have shown it can help, doctors now need to check how safe it is when taken over a longer time.
By following people taking either a 100 mg or 200 mg dose, the researchers can see how the body handles the treatment over the long haul. They will check if the medicine keeps bowel symptoms settled and carefully watch for any unwanted side effects, helping to ensure the treatment is both safe and effective for future care.
Key takeaways
- Tests the long-term safety of filgotinib tablets for ulcerative colitis.
- Open to adults aged 18 and older.
- Involves taking a daily tablet and attending regular clinic check-ups.
- Doctors will closely monitor your blood, vitals, and bowel symptoms.
- Taking part is voluntary, and you are free to stop at any time.
Who may be eligible?
This study is for adults aged 18 and older who have been diagnosed with ulcerative colitis. Both men and women can take part. Because this is an extension study, it is generally designed for people who have already taken part in an earlier trial testing filgotinib.
To join, participants need to be well enough to attend regular hospital check-ups and be willing to take their tablets as directed. If you have other major medical conditions, serious active infections, or are pregnant or planning a family, this study might not be the right fit for you.
The study team will review your complete medical history and carry out health checks before you can join, making sure that taking part is as safe as possible.
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.
- I am aged 18 or over.
- I have a confirmed diagnosis of ulcerative colitis.
- I have previously taken part in an earlier filgotinib clinical trial (if required).
- I can attend regular hospital appointments for check-ups and blood tests.
- I am not currently dealing with a serious, untreated infection.
What does participation involve?
If you take part, you will be asked to take a filgotinib tablet (either 100 mg or 200 mg) once a day. You will need to attend regular hospital visits so the study doctors can see how you are doing. At these appointments, the team will check your blood pressure and pulse, take blood and urine samples, and ask about any new symptoms or side effects. You will also answer simple questions about your bowel habits to track your colitis. The study lasts over an extended period, often lasting one or more years, and you will have follow-up checks at the end to make sure you remain well.
Potential risks and benefits
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Common questions
What is filgotinib?
Filgotinib is a daily tablet that helps reduce inflammation in the gut by calming an overactive immune system.
How is the medicine taken?
It is taken as a simple tablet by mouth, usually once every day with water.
Will I have to pay for the study treatment?
No, all study tablets, tests, and appointments are provided free of charge, and travel expenses are often covered.
Can I leave the study if I want to stop?
Yes, you can leave the study at any point without giving a reason, and your normal medical care will continue.
Will I definitely receive the active medicine?
In this long-term study, participants typically receive an active dose of filgotinib (either 100 mg or 200 mg), rather than a dummy pill.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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