A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
This study is looking at two different medications, guselkumab and risankizumab, for people in the UK who have Crohn's disease. Crohn's disease is a long-term condition that causes inflammation in the digestive system. We're interested in people whose Crohn's is moderate to severe. The main goal is to find out which of these two medicines is more effective at controlling the disease. This could lead to better treatment options for people living with this challenging condition. Taking part would involve regular check-ups and assessments to monitor your health and how well the treatment is working.
At a glance
What is this study about?
Crohn's disease is a long-term condition where parts of your digestive system become inflamed. This can cause various symptoms like tummy pain, diarrhoea, weight loss, and extreme tiredness. Sometimes, this inflammation can be quite severe, significantly affecting daily life.
Researchers are running a study to compare two medicines, guselkumab and risankizumab, both of which are designed to reduce this inflammation. The aim is to see how well each medicine works in people with moderate to severe Crohn's disease. By comparing them directly, doctors hope to understand which one might offer a better treatment option for patients.
Understanding which treatments are most effective is really important for improving the lives of people with Crohn's disease. This study is a 'Phase 3' trial, which means these medicines have already been tested in earlier stages and are now being compared more widely to confirm their benefits and safety.
Key takeaways
- Compares two medicines (guselkumab and risankizumab) for Crohn's disease.
- For people with moderate to severe Crohn's.
- Aims to find out which medicine is more effective.
- Involves regular health checks and tests.
- You can ask any questions and withdraw at any time.
Who may be eligible?
To be considered for this study, you need to have Crohn's disease that has been diagnosed for at least 12 weeks. Your doctor will need to confirm that your Crohn's is currently moderately to severely active. This will involve checking your symptoms and looking inside your bowel using a camera (endoscopy) to make sure there's enough inflammation there for the study.
There are also some reasons why you might not be able to join. For example, if you have complications from your Crohn's, like blockages, or if you've had recent surgery on your bowel. Also, if you have any serious infections or certain other major health problems, the study might not be suitable for you.
Your study doctor will discuss all these points with you and carry out a full assessment to see if this study is a good fit 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.
- Do I have Crohn's disease diagnosed for at least 3 months?
- Do I currently have moderate to severe Crohn's symptoms?
- Am I generally aged 18 or over?
- Have I had recent bowel surgery (within the last 6 months)?
- Do I currently have any serious infections?
What does participation involve?
If you join the study, you'll be given either guselkumab or risankizumab. You'll have regular appointments where doctors will check your general health, assess your symptoms, and take blood samples. You might also have more endoscopies to see how your bowel is responding to the treatment. The study will last for a period of time, which your doctor will explain, including follow-up visits after the main treatment period. You'll need to follow specific instructions about other medicines you're taking for your Crohn's disease during the study.
Potential risks and benefits
Locations (30)
- Digestive Health Specialists of the SoutheastVerified postcodeDothan, United States· Recruiting
- Clinnova ResearchVerified postcodeAnaheim, United States· Recruiting
- United GastroenterologistsVerified postcodeLos Alamitos, United States· Recruiting
- TLC Clinical Research IncVerified postcodeLos Angeles, United States· Recruiting
- Hoag Memorial HospitalVerified postcodeNewport Beach, United States· Suspended
- Peak Gastroenterology AssociatesVerified postcodeColorado Springs, United States· Recruiting
- Sanchez Clinical Research, IncVerified postcodeMiami, United States· Recruiting
- GCP Clinical ResearchVerified postcodeTampa, United States· Recruiting
- Cotton-O'Neil Clinical Research CenterVerified postcodeTopeka, United States· Recruiting
- Westchester Putnam GastroenterologyVerified postcodeCarmel, United States· Recruiting
- New York Gastroenterology AssociatesVerified postcodeNew York, United States· Recruiting
- Charlotte Gastroenterology and Hepatology, PLLCVerified postcodeCharlotte, United States· 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 and diarrhoea.
What are guselkumab and risankizumab?
These are two different medications being tested to see how well they can reduce inflammation in people with Crohn's disease.
Will I know which medicine I'm getting?
In some studies, you might not know which medicine you're taking (this is called 'blinded'), to keep the results fair. Your doctor will explain this.
How long does the study last?
The study involves regular visits and lasts for a specific period, plus follow-up. Your study team will tell you the exact time commitment.
Can I stop participating if I want to?
Yes, you are free to leave the study at any time, for any reason, without it affecting your usual medical care.
How to find out more
Study Contact
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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