A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease
This research study is for children and young people aged 2 to 17 who have Crohn's disease that is moderate to severe and hasn't improved with other treatments. The study is investigating a medicine called risankizumab, which is already used for adults with certain conditions, including Crohn's. The main goals are to check if risankizumab is safe for this age group, how well it helps control Crohn's symptoms, and how the body handles the medicine. Participants will receive the medicine in different ways and will be closely monitored by doctors over several years. About 110 young people worldwide will take part in this important research.
At a glance
What is this study about?
Crohn's disease is a condition that affects your gut and can cause symptoms like tummy pain, diarrhoea (sometimes with blood), weight loss, and fever. It can be a very challenging condition, especially for children and young people.
This study is looking into a medication called risankizumab, which is already approved for adults with Crohn's disease and some other conditions. The researchers want to find out if it's a good and safe option for children and young people aged between 2 and 17 whose Crohn's hasn't got better with other common treatments. They will also learn how the medicine acts in the bodies of younger patients and if it can help reduce their symptoms and improve their overall health.
Taking part in this study means doctors can closely watch how risankizumab works and gather important information that could help many other young people with Crohn's in the future. The study involves different stages where the medicine will be given in various ways, either into a vein (like a drip) or as an injection under the skin, with careful monitoring throughout.
Key takeaways
- This study is for young people aged 2-17 with active Crohn's disease.
- It's testing a medicine called risankizumab, which is new for this age group.
- The study checks if the medicine is safe and helps control Crohn's symptoms.
- Participation involves regular hospital visits and check-ups.
- The medicine will be given either through a drip or as an injection.
- You can stop taking part at any time.
Who may be eligible?
To join this study, you would need to be a child or young person between 2 and 17 years old with moderate to severe Crohn's disease. This means your Crohn's is currently quite active and has been confirmed by medical tests like an endoscopy. It's also important that other typical treatments for Crohn's haven't worked well for you, or you couldn't tolerate them.
There are certain reasons why someone might not be able to join. For example, if you have a rare genetic condition called hereditary fructose intolerance, or if you've had a bad reaction to similar medicines before. The study also cannot accept participants who have other severe gut conditions, certain immune problems, or active complications of Crohn's that might need surgery soon, like an abscess. Also, if you've had a lot of bowel surgeries or a recent one, this might mean you can't take part.
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 2 and 17 years old?
- Do you have moderate to severe Crohn's disease that's currently active?
- Have other Crohn's treatments not worked well for you or caused problems?
- Do you *not* have certain other serious health problems or recent surgeries listed by the doctors?
- Have you *not* had a bad allergic reaction to similar medicines in the past?
What does participation involve?
If you decide to take part, you'll have regular visits to a hospital or clinic. Initially, you'll receive the study medicine through a drip into a vein for 12 weeks. After that, for about a year, you'll usually switch to receiving the medicine as an injection under the skin. Some participants might continue receiving the medicine for up to four more years, depending on how they respond.
Throughout the study, doctors and nurses will do various checks to see how you're doing. This will include medical examinations, blood tests, and asking you to fill out questionnaires about how you're feeling and your symptoms. The study involves close medical attention and regular check-ups to make sure the treatment is safe and effective. The total time you'd be involved in the study, including follow-up after treatment, could be several years.
Potential risks and benefits
Locations (85)
- Phoenix Children's Hospital /ID# 255766Verified postcodePhoenix, United States· Recruiting
- Arkansas Children's Hospital /ID# 255762Verified postcodeLittle Rock, United States· Recruiting
- UCSF Benioff Children's Hospital - Oakland /ID# 258327Verified postcodeOakland, United States· Recruiting
- Children's Hospital Colorado - Aurora /ID# 255764Verified postcodeAurora, United States· Recruiting
- Arnold Palmer Hospital for Children Center Digestive Health and Nutrition-Orland /ID# 255437Verified postcodeOrlando, United States· Recruiting
- Indiana University Health Riley Hospital for Children /ID# 256454Verified postcodeIndianapolis, United States· Recruiting
- Massachusetts General Hospital /ID# 255767Verified postcodeBoston, United States· Recruiting
- MNGI Digestive Health, P. A. /ID# 255366Verified postcodeMinneapolis, United States· Recruiting
- Goryeb Childrens Hospital /ID# 256452Verified postcodeMorristown, United States· Recruiting
- Icahn School of Medicine at Mount Sinai /ID# 254880Verified postcodeNew York, United States· Recruiting
- Cleveland Clinic - Cleveland /ID# 256453Verified postcodeCleveland, United States· Recruiting
- Uza /Id# 255114Verified postcodeEdegem, Belgium· Recruiting
Common questions
What is Crohn's disease?
Crohn's disease is a long-term condition that causes inflammation in your digestive system, leading to symptoms like tummy pain, diarrhoea, and weight loss.
What is risankizumab?
Risankizumab is a medicine that works by calming down parts of your immune system that cause inflammation. It's already approved for adults with Crohn's.
How will I receive the medicine?
Initially, you'll get the medicine through a drip into a vein, and later, it will usually be given as an injection under the skin.
How long will the study last?
The study involves different stages, and your participation, including follow-up, could last several years, depending on how you respond to the treatment.
Can I stop being part of the study at any time?
Yes, you or your parents can decide to stop participating in the study at any point, and it won't affect your future 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.
Interested in taking part?
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