A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
This study is investigating a medication called risankizumab for children and young people aged 2 to 17 who have moderate to severe ulcerative colitis (UC). UC is a condition causing inflammation and bleeding in the large bowel. Risankizumab is already approved for adults with UC in many countries. This research aims to understand how the medicine works in younger bodies, how safe it is, and how effective it is at reducing UC symptoms. Participants will receive risankizumab, initially through a drip, then by injection. The study will look at side effects and how much the disease improves. It will involve about 120 young people globally, over several years, with regular hospital visits and health checks.
At a glance
What is this study about?
Ulcerative colitis (UC) is a long-term condition where the lining of your large bowel (colon and rectum) becomes inflamed and develops tiny ulcers. This can lead to symptoms like tummy pain, urgent trips to the toilet, and blood in your poo. Living with UC can be challenging, especially for children and young people, as it can affect their daily lives and growth.
This study is focusing on a medicine called risankizumab, which is already used for adults with moderate to severe UC. Researchers want to find out if it's a suitable and effective treatment for younger individuals. They'll be looking at how the medicine is processed by the body in different age groups – from young children aged 2 up to teenagers aged 17 – and whether it helps to calm down the inflammation in their bowel. The goal is to gather important information to potentially offer a new treatment option for young people living with this condition.
Taking part in this study means doctors can closely monitor how risankizumab works in young bodies. This includes carefully checking for any side effects and seeing how much their UC symptoms improve. The information learned from these young participants is vital for understanding how best to use this medication in the future, providing hope for better management of UC in children and teenagers.
Key takeaways
- This study evaluates risankizumab for children and young people with ulcerative colitis (UC).
- It aims to check the medicine's safety, effectiveness, and how it works in younger bodies.
- Participants must have active UC and not have responded well to previous treatments.
- Involves initial intravenous doses, followed by subcutaneous injections over several years.
- Regular hospital visits and health checks are required.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be able to join this study, children and young people need to have been diagnosed with ulcerative colitis (UC) for at least three months. Their UC must be active, meaning it's currently causing noticeable symptoms, and doctors will confirm this with specific medical scores and a camera test of their bowel.
Another important requirement is that their current UC treatment hasn't worked well enough, or they've had problems with it. This could include standard medications like aminosalicylates, steroids (taken by mouth or as an enema), immunosuppressants, or other advanced treatments known as 'biologics'.
You won't be able to join if you've recently had major surgery, or if you're planning to have one soon. Also, if you have other serious medical conditions that might make it unsafe to take part, or if the doctors think it would interfere with the study's results, then unfortunately, you wouldn't be suitable. This is to ensure the safety of all participants and the quality of the research.
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.
- Is your child aged between 2 and 17 years old?
- Does your child have an official diagnosis of ulcerative colitis (UC) for at least three months?
- Is your child's UC currently active and causing symptoms?
- Has your child's UC not responded well enough to previous standard treatments, or have they had problems with those treatments?
- Has your child NOT had any major surgery recently (in the last 12 weeks) or planned during the study?
- Does your child NOT have other serious health conditions that could make taking part unsafe?
What does participation involve?
If your child takes part in this study, they will receive the study medicine, risankizumab. Initially, for the first 12 weeks, the medication will be given through a drip into a vein (intravenously). After this, they will switch to receiving the medicine as an injection under the skin (subcutaneously) at regular intervals for up to several years.
Participation involves frequent visits to a hospital or clinic, which might be more often than typical UC care. During these visits, doctors and nurses will carry out various checks including physical examinations, blood tests, and assessments for any side effects. You and your child will also be asked to complete questionnaires about their health and symptoms. The full study could last for several years, plus a follow-up period of about 140 days after the last dose of medicine. Throughout the study, the medical team will be there to support you and answer any questions.
Potential risks and benefits
Locations (48)
- Phoenix Children's Hospital /ID# 273015Verified postcodePhoenix, United States· Recruiting
- Rady Children's Hospital /ID# 271873Verified postcodeSan Diego, United States· Recruiting
- University of California San Francisco - Mission Bay /ID# 273022Verified postcodeSan Francisco, United States· Recruiting
- Nicklaus Children'S Hospital - Miami - Southwest 62nd Avenue /ID# 271585Verified postcodeMiami, United States· Recruiting
- Childrens Center For Digestive Health Care /ID# 273228Verified postcodeAtlanta, United States· Recruiting
- University of Chicago Medical Center /ID# 271588Verified postcodeChicago, United States· Recruiting
- Goryeb Children's Hospital /ID# 271801Verified postcodeMorristown, United States· Recruiting
- University Hospitals Cleveland Medical Center /ID# 271831Verified postcodeCleveland, United States· Recruiting
- The Children's Hospital of Philadelphia /ID# 273222Verified postcodePhiladelphia, United States· Recruiting
- Upmc Children'S Hospital Of Pittsburgh /ID# 272328Verified postcodePittsburgh, United States· Recruiting
- Patewood Medical Campus /ID# 272477Verified postcodeGreenville, United States· Recruiting
- Cliniques Universitaires UCL Saint-Luc /ID# 270123Verified postcodeBrussels, Belgium· Recruiting
Common questions
What is ulcerative colitis?
Ulcerative colitis is a long-term condition where the lining of your large bowel (colon and rectum) becomes inflamed and develops small ulcers, causing symptoms like tummy pain and urgent trips to the toilet.
What is risankizumab?
Risankizumab is a medicine that helps reduce inflammation. It's already approved for adults with ulcerative colitis in many countries, and this study is looking at its use in children and young people.
How will my child receive the medicine?
Initially, risankizumab will be given through a drip (intravenously) for 12 weeks. After that, it will be given as an injection under the skin (subcutaneously) for the rest of the study.
How long will the study take?
The study involves different phases that could last several years in total, plus a follow-up period of about 140 days after the last dose of medicine.
Can I stop my child's participation at any time?
Yes, you are free to withdraw your child from the study at any point, and this will not affect their regular medical care.
How to find out more
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Always speak to your GP or specialist before deciding to take part in a study.
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