I6T-MC-AMBA - A Multicenter, Phase 3, Open-Label Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age with Moderately to Severely Active Ulcerative Colitis
This study is testing a medicine called Mirikizumab (you might hear it called Omvoh) for children and teenagers between 2 and 18 years old who have moderate to severe ulcerative colitis. Ulcerative colitis is a long-term condition that causes inflammation in the large intestine. The main goal is to find out how many young people who respond well to the medicine at the beginning are still feeling better after one year. We'll also be checking how the medicine moves through the body and if it's safe. This information will help us understand if Mirikizumab could be a good treatment option for young people with this condition.
At a glance
What is this study about?
Ulcerative colitis is a long-lasting condition where the lining of your large intestine (also called your colon and rectum) gets inflamed and develops tiny sores. This can cause tummy pain, going to the toilet a lot, and sometimes blood in your poo. When it's 'moderately to severely active,' it means these symptoms are quite troublesome and have a big impact on daily life.
This study is focusing on children and teenagers because their bodies react differently to medicines than adults. We want to find a safe and effective treatment specifically for them. The medicine being tested is called Mirikizumab, also known as Omvoh. It's already approved for adults, and now we're exploring if it can help younger patients too.
The main aim of this study is to see how many young people who start feeling better with Mirikizumab after 12 weeks are still doing well after a whole year. We will carefully watch how the medicine works in their bodies and check for any side effects to make sure it's safe. This kind of research is really important to improve the lives of young people living with ulcerative colitis.
Key takeaways
- New medicine (Omvoh) for moderate to severe ulcerative colitis in young people.
- Aims to check safety and how well it helps control symptoms.
- Involves children and teenagers aged 2 to under 18.
- Study lasts for about one year.
- Regular check-ups and medical tests will be part of taking part.
- Participation is completely voluntary.
Who may be eligible?
To join this study, children and teenagers need to have been diagnosed with moderate to severe ulcerative colitis. This means their condition is actively causing symptoms that affect their daily life.
There are some specific health checks doctors will need to do to make sure the study is a safe and good fit. These might include reviewing your child's medical history and current health carefully.
It's important that your child fits all the study requirements. The study team will explain everything fully and answer any questions you have to help you understand if your child can take part.
- Is my child between 2 and under 18 years old?
- Does my child have a diagnosis of moderate to severe ulcerative colitis?
- Is my child generally well enough to take part in a study?
- Am I, as a parent or guardian, able to commit to regular hospital visits for my child?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If your child takes part in this study, they will receive the study medicine, Mirikizumab (Omvoh), either as an infusion (given through a drip into a vein) or as an injection using a pre-filled syringe. Initially, the medicine will be given as an infusion, and then it might switch to injections. There will be regular visits to the clinic so doctors can monitor your child's health, check how they are responding to the medicine, and look for any side effects. These visits will involve physical examinations, blood tests, and sometimes stool samples or other assessments to track their ulcerative colitis. The study will continue for about a year to see the long-term effects of the treatment. The research team will explain the full schedule of visits and procedures in detail before you decide to take part.
Potential risks and benefits
Locations (7)
- —Belgium
- —Portugal
- —Poland
- —Italy
- —Netherlands
- —Germany
- —France
Common questions
What is ulcerative colitis?
It's a long-term condition that causes swelling and sores in the lining of your large intestine (colon and rectum), leading to tummy pain and needing to go to the toilet often.
What is Mirikizumab (Omvoh)?
It's a medicine being tested in this study to see if it can help children and teenagers with moderate to severe ulcerative colitis.
Who can join this study?
Children and teenagers aged 2 to under 18 who have moderate to severe ulcerative colitis and meet other specific health requirements can be considered.
How long does the study last?
The main part of the study assessing the medicine's effect will last about a year.
Will my child get the actual medicine or a placebo?
In this study, all participants will receive the active study medicine, Mirikizumab (Omvoh).
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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