I6T-MC-AMBZ - A Multicenter, Phase 3b, Open-Label, Single-Arm Study to Investigate Bowel Urgency and Its Relationship With Other Outcome Measures in Adults With Moderately to Severely Active Ulcerative Colitis Treated With Mirikizumab
This research study is for adults who have ulcerative colitis, a long-term condition that causes inflammation in the large bowel. Participants in the study have moderate to severe active ulcerative colitis. The main goal is to see how a new medicine, mirikizumab, affects bowel urgency – that feeling of needing to go to the toilet very suddenly. Scientists want to understand if this medicine can make that feeling less intense over 12 weeks. The study will also look at how mirikizumab affects other symptoms of ulcerative colitis to get a full picture of its effects. It’s an 'open-label' study, which means both participants and their doctors will know they are receiving mirikizumab.
At a glance
What is this study about?
This study is called I6T-MC-AMBZ, and it's looking into a new treatment called mirikizumab for people living with a condition called ulcerative colitis. Ulcerative colitis is a long-term illness where the lining of your large bowel (colon and rectum) becomes inflamed and develops tiny ulcers. This can cause symptoms like tummy pain, bloody stools, and a frequent or urgent need to go to the toilet.
In this study, researchers are particularly interested in a symptom called 'bowel urgency.' This is when you feel a sudden, strong need to pass a bowel motion that is hard to control. The main aim of the study is to find out if mirikizumab can help reduce how often and how strongly people experience this bowel urgency over a 12-week period. They'll be using a special score to measure this change.
This is a 'Phase 3b' study, which means the medicine has already been tested in earlier studies and shown promise. It's an open-label study, meaning everyone involved, including the participants and their doctors, will know that mirikizumab is being given. The study will help doctors better understand how mirikizumab works and if it can improve the daily lives of people with moderately to severely active ulcerative colitis.
Key takeaways
- This study is testing a new medicine called mirikizumab for ulcerative colitis.
- The main focus is to see if it helps reduce bowel urgency.
- It's for adults (18+) with moderately to severely active ulcerative colitis.
- Participation involves receiving mirikizumab and regular check-ups.
- The initial study period for bowel urgency is 12 weeks.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. There is no upper age limit, so older adults can also take part.
Both men and women are welcome to participate in this study. The research is specifically looking for people who have been diagnosed with ulcerative colitis that is currently considered 'moderately to severely active.' This means your symptoms are more than just mild and are actively affecting you.
Beyond these basic requirements, there will be other specific health checks and medical history reviews to make sure the study medicine is safe and appropriate for you, and that the study results will be clear and reliable. Your doctor will be able to tell you if you meet all the necessary criteria.
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 ulcerative colitis?
- Is your ulcerative colitis currently considered 'moderately to severely active'?
- Are you willing to attend regular clinic visits?
- Are you able to understand and follow study instructions?
What does participation involve?
If you decide to take part in this study, you will be given the medicine called mirikizumab. As it's an 'open-label' study, you and your doctors will know you are receiving this treatment. Over the course of the study, you would have several visits to the clinic. These visits would involve regular check-ups, where doctors will monitor your health and how you are responding to the medication. This might include answering questions about your symptoms, having physical examinations, and providing blood or other samples.
Doctors will pay close attention to your bowel urgency, asking you to rate it regularly. They'll also check other aspects of your ulcerative colitis. The main part of the study where they look for changes in bowel urgency lasts for 12 weeks. After this initial period, there will be further follow-up visits to continue monitoring your health and the effects of the treatment. The total length of your participation would be explained in detail by the study team.
Potential risks and benefits
Locations (9)
- —UnverifiedAustria
- —UnverifiedSlovakia
- —UnverifiedCzechia
- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedHungary
- —UnverifiedBelgium
- —UnverifiedPoland
- —UnverifiedItaly
Common questions
What is ulcerative colitis?
Ulcerative colitis is a long-lasting condition that causes irritation and sores in the lining of your large bowel.
What does 'bowel urgency' mean?
It's a sudden, strong, and difficult-to-control need to have a bowel movement.
What is mirikizumab?
Mirikizumab is the name of the new medicine being tested in this study for treating ulcerative colitis.
Will I know if I'm getting the study medicine?
Yes, this is an 'open-label' study, so you and your doctor will know you're receiving mirikizumab.
How long does the main part of the study last?
The main part of the study where they look at bowel urgency lasts for 12 weeks.
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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