A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab versus Risankizumab in the Treatment of Participants with Moderately to Severely Active Crohn’s Disease
This research study is looking at two medicines already approved for use, Guselkumab and Risankizumab (often called Skyrizi), to treat adults living with Crohn's disease that is moderate or severe. Crohn's disease is a condition that causes inflammation in the digestive system. The study wants to find out if one of these medicines offers a deeper and longer-lasting improvement in symptoms compared to the other. Researchers will compare how well each medicine works to reduce the disease activity and improve how people feel, as well as checking for any side effects. The main goal is to see which treatment leads to a state called 'deep remission' after about one year, meaning symptoms are much less severe. Participants will receive one of the two study medicines.
At a glance
What is this study about?
This study is about people who have Crohn's disease that is moderate to severe. Crohn's disease is a long-lasting condition where parts of your digestive system become inflamed. This can cause symptoms like tummy pain, diarrhoea, and tiredness. Even though there are treatments available, sometimes people still have a lot of symptoms.
Researchers want to compare two medicines that are already used to treat Crohn's disease: Guselkumab and Risankizumab (which you might know as Skyrizi). Both of these medicines work by calming down the inflammation in your body. This study wants to see which one works better and is safer in the long run. They are especially interested in helping people reach 'deep remission,' which means their disease is much less active and they feel significantly better.
By taking part, you would be helping doctors understand more about how these medicines work. This information can help improve treatments for people with Crohn's disease in the future, potentially leading to better quality of life for many.
Key takeaways
- Compares two existing Crohn's disease medicines: Guselkumab and Risankizumab (Skyrizi).
- For adults with moderate to severe Crohn's disease.
- Aims for 'deep remission' after one year.
- Will assess which medicine works best and is safest.
- Participation involves regular clinic visits and close monitoring.
Who may be eligible?
To be part of this study, you need to be an adult, 18 years old or older. There is no upper age limit, so people of all adult ages can be considered.
The study is for people who have been diagnosed with Crohn's disease that is currently moderate to severe. This means your Crohn's disease is causing significant symptoms and impact on your daily life.
Anyone, regardless of their sex, can join this study if they meet the other requirements. The research team will carefully check your medical history to make sure the study is a safe and suitable option for you.
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 18 years old or older?
- Have you been diagnosed with Crohn's disease?
- Is your Crohn's disease currently considered moderate to severe?
- Are you willing to potentially receive either Guselkumab or Risankizumab (Skyrizi)?
- Are you able to attend regular clinic appointments?
What does participation involve?
If you join this study, you would be randomly assigned to receive one of the two study medicines: either Guselkumab or Risankizumab (Skyrizi). Neither you nor your doctor would choose which medicine you get. You would receive the medicine as either an infusion (given through a drip) or as an injection.
Throughout the study, you would have regular visits to the clinic. During these visits, the research team would monitor your health carefully. This would involve checks like blood tests, physical examinations, and asking you about your symptoms and how you are feeling. The main aim is to see how well the medicine is working and to keep an eye on any side effects. The study will last for about one year (52 weeks), and there will likely be follow-up appointments after that.
Potential risks and benefits
Locations (13)
- —UnverifiedSlovakia
- —UnverifiedGermany
- —UnverifiedDenmark
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedNetherlands
- —UnverifiedBelgium
- —UnverifiedPoland
- —UnverifiedSweden
- —UnverifiedAustria
- —UnverifiedCzechia
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 are Guselkumab and Risankizumab (Skyrizi)?
These are two medicines already used to treat Crohn's disease. They work by reducing the inflammation in your body.
What does 'deep remission' mean?
It means your Crohn's disease is much less active, and your symptoms have significantly improved, making you feel much better.
Will I know which medicine I'm getting?
No, you'll be randomly assigned to receive one of the two medicines, and neither you nor your doctor will choose.
How long will the study last?
The main part of the study will last for about one year (52 weeks), with some follow-up after that.
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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