A Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease
This research study is for children and teenagers who have moderately to severely active Crohn's disease. Researchers are testing a medicine called Stelara. The main goal is to find out if Stelara can help these young people feel much better after about eight weeks. First, participants will receive Stelara through a drip (into a vein) in a hospital setting. After this initial treatment, they will then receive the medicine as a simple injection under the skin, which can often be given at home or in a clinic. The study will also look at how safe the medicine is and how the body uses it. This is a "Phase 3" study, which means it's one of the final stages of testing before a new medicine might become widely available.
At a glance
What is this study about?
This study is investigating a treatment called Stelara for young people living with Crohn's disease. Crohn's disease is a long-term condition where parts of the digestive system become inflamed. This can cause symptoms like tummy pain, diarrhoea, and tiredness, and can seriously affect daily life. This particular study focuses on children and teenagers whose Crohn's is quite active, meaning their symptoms are bothersome and affecting their quality of life.
The main purpose of the study is to see if Stelara can help these young people go into "remission." Remission means that their symptoms become much less noticeable or go away completely, allowing them to feel much better. The study will first give Stelara through a drip, which is a common way to quickly get medication into the body. After this initial stage, participants will switch to receiving Stelara through an injection under the skin, which is often easier and more convenient for long-term treatment.
Researchers are also very interested in understanding how safe Stelara is for children and teenagers, and how their bodies process the medicine. By carefully studying these things, doctors can decide if Stelara is a good and safe treatment option for this age group in the future. This is a very important step in developing new and effective ways to manage Crohn's disease in young people.
Key takeaways
- This study is for children and teenagers with active Crohn's disease.
- It's testing a medicine called Stelara to see if it makes symptoms better.
- The medicine is given first by a drip, then by an injection.
- Safety and how the body handles the medicine are also being carefully checked.
- It's a Phase 3 study, a key step before a medicine can be widely used.
Who may be eligible?
This study is looking for children and teenagers who have been diagnosed with Crohn's disease. Specifically, they need to have "moderately to severely active" Crohn's.
"Moderately to severely active" means that their Crohn's symptoms are quite noticeable and are causing problems in their daily life. Doctors will have specific ways to measure how active the disease is to make sure participants meet this requirement.
Both boys and girls can take part in this study, and there are no specific age limits mentioned beyond being a child or teenager affected by Crohn's disease.
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.
- Do I have Crohn's disease?
- Are my Crohn's symptoms currently bothering me or affecting my daily life?
- Am I a child or teenager?
- Am I willing to have treatment given both as a drip and later as an injection?
What does participation involve?
If you decide to take part in this study, you will first receive the study medicine, Stelara, through a drip into a vein, usually in a hospital or clinic setting. This is called the 'induction' phase and typically happens for a few weeks. Following this, you will be given the medicine as an injection under the skin. These injections might be given at a clinic or you might learn to give them yourself at home, with guidance.
You will have regular visits to the clinic so doctors can check how you are doing, measure your symptoms, and make sure the medicine is safe and working well. These visits will involve check-ups, potentially blood tests, and discussions about any side effects. Some visits might also involve giving you the medication. The total length of time you will be involved in the study will be explained in detail by the research team.
Potential risks and benefits
Locations (4)
- —UnverifiedHungary
- —UnverifiedGermany
- —UnverifiedBelgium
- —UnverifiedPoland
Common questions
What is Crohn's disease?
Crohn's disease is a condition where parts of your digestive system become inflamed, causing symptoms like tummy pain, diarrhoea, and tiredness.
What is Stelara?
Stelara is the name of the medicine being tested in this study. It's designed to help reduce the inflammation in Crohn's disease.
How will I receive the medicine?
Initially, you'll receive it through a drip, and then later as an injection under the skin, similar to a jab.
What does 'Phase 3' mean?
Phase 3 means this is one of the final stages of testing a medicine on a larger group of people to confirm its effectiveness and safety before it could be widely used.
Can I stop being in the study if I change my mind?
Yes, you can absolutely decide to stop participating at any point, and it won't affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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