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RecruitingPHASE3INTERVENTIONAL

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

Status
Recruiting
Phase
PHASE3
Sponsor
AbbVie
Enrolment target
110
Start
11 Dec 2023
Estimated completion
01 Apr 2029

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.

  1. Are you between 2 and 17 years old?
  2. Do you have moderate to severe Crohn's disease that's currently active?
  3. Have other Crohn's treatments not worked well for you or caused problems?
  4. Do you *not* have certain other serious health problems or recent surgeries listed by the doctors?
  5. Have you *not* had a bad allergic reaction to similar medicines in the past?
Answer every question to see your result.

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

Taking part in a study like this could offer potential benefits, such as gaining access to a new treatment option for your Crohn's disease that hasn't responded to other medicines. You would also receive very close medical care and monitoring. However, there are also potential risks. The treatment might cause side effects, which the medical team will explain to you. It's also possible the treatment might not work for everyone. There might be more visits and tests than your usual care, which could be a bigger burden. You are free to withdraw from the study at any time, for any reason, without affecting your regular medical care.

Locations (85)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Phoenix Children's Hospital /ID# 255766
    Verified postcode
    Phoenix, United States· Recruiting
  • Arkansas Children's Hospital /ID# 255762
    Verified postcode
    Little Rock, United States· Recruiting
  • UCSF Benioff Children's Hospital - Oakland /ID# 258327
    Verified postcode
    Oakland, United States· Recruiting
  • Children's Hospital Colorado - Aurora /ID# 255764
    Verified postcode
    Aurora, United States· Recruiting
  • Arnold Palmer Hospital for Children Center Digestive Health and Nutrition-Orland /ID# 255437
    Verified postcode
    Orlando, United States· Recruiting
  • Indiana University Health Riley Hospital for Children /ID# 256454
    Verified postcode
    Indianapolis, United States· Recruiting
  • Massachusetts General Hospital /ID# 255767
    Verified postcode
    Boston, United States· Recruiting
  • MNGI Digestive Health, P. A. /ID# 255366
    Verified postcode
    Minneapolis, United States· Recruiting
  • Goryeb Childrens Hospital /ID# 256452
    Verified postcode
    Morristown, United States· Recruiting
  • Icahn School of Medicine at Mount Sinai /ID# 254880
    Verified postcode
    New York, United States· Recruiting
  • Cleveland Clinic - Cleveland /ID# 256453
    Verified postcode
    Cleveland, United States· Recruiting
  • Uza /Id# 255114
    Verified postcode
    Edegem, 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

ABBVIE CALL CENTER

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Assess Adverse Events, Change in Disease Activity…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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