A Phase IIa, randomised, double-blind, placebo-controlled trial to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of BI 706321 orally administered for 12 weeks in patients with Crohn`s Disease (CD) receiving ustekinumab induction treatment
This research study is for people with Crohn's disease who are starting treatment with Stelara. It's investigating a new medication called BI 706321. We want to find out if this new drug is safe to use and how well it helps manage Crohn's symptoms when taken with Stelara. The study will also look at how the new medication moves through and affects the body. Participants will receive either the new medication or a ‘dummy’ pill (placebo) for 12 weeks, while also receiving their usual Stelara treatment. We'll be carefully monitoring changes in their Crohn's disease over this time.
At a glance
What is this study about?
This study is for individuals living with Crohn's disease, a long-term condition that causes inflammation in the digestive system. We are exploring a new medication, currently known as BI 706321, to see if it can be a helpful addition to treatment for people who are already receiving or starting a treatment called Stelara (ustekinumab).
The main goal is to understand if BI 706321 is safe and how well it works to reduce inflammation in the gut, which is a key part of Crohn's disease. We're particularly interested in how the inside of the gut changes, as seen through a procedure called an endoscopy. This will help us compare how well people do on the new medication versus those who receive a 'dummy' pill without any active ingredients.
By taking part, you would help us learn more about potential new ways to manage Crohn's disease. If BI 706321 proves to be safe and effective, it could offer another option for improving the lives of people with this condition. Your involvement is crucial to advancing medical knowledge and potentially finding better treatments.
Key takeaways
- This study is for adults with Crohn's disease who are starting Stelara treatment.
- It's testing a new medication (BI 706321) alongside Stelara to see if it's safe and effective.
- You might receive the new drug or a dummy pill, taken for 12 weeks.
- Participation involves regular clinic visits, blood tests, and endoscopies.
- Your involvement could help develop new treatments for Crohn's disease.
- You can leave the study at any time without affecting your normal care.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. Both men and women are welcome to take part.
You would specifically need to have an active diagnosis of Crohn's disease and be scheduled to begin treatment with ustekinumab, known by its brand name Stelara. The study will assess how the new medication works alongside your initial Stelara treatment.
There will be other detailed medical criteria that the study doctors will check to make sure the study is a good fit for you and that it's safe for you to participate.
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?
- Do you have a diagnosis of Crohn's disease?
- Are you about to start (or have recently started) Stelara (ustekinumab) treatment?
- Are you able to attend regular clinic appointments and undergo medical tests like blood draws and endoscopies?
What does participation involve?
If you decide to take part, you would receive either the new study medication (BI 706321) or an inactive 'dummy' pill (placebo). This would be taken alongside your regular Stelara treatment for 12 weeks. Your condition will be closely monitored throughout this period and for some time afterwards.
You would have several visits to the clinic for assessments, which might include blood tests, stool samples, and endoscopies (a procedure where a thin, flexible tube with a camera is used to look inside your digestive system). These assessments help us understand how your body is responding to the treatment and to keep an eye on your overall health.
The total duration of your involvement, including follow-up after stopping the study medication, will be explained fully by the study team. You'll receive clear instructions on when and how to take your medication, and who to contact if you have any questions or concerns.
Potential risks and benefits
Locations (6)
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedCzechia
- —UnverifiedGermany
- —UnverifiedPoland
- —UnverifiedHungary
Common questions
What is Crohn's disease?
Crohn’s disease is a long-term condition where parts of your digestive system become inflamed.
What is Stelara?
Stelara (ustekinumab) is a common medication used to treat chronic inflammatory conditions like Crohn's disease.
What is a 'dummy' pill (placebo)?
A dummy pill contains no active medicine but looks exactly like the study drug. Some people get the dummy pill so we can compare its effects to the active medicine.
Will I know if I'm getting the new drug or the dummy pill?
No, this is a 'blind' study, meaning neither you nor your study doctor will know which treatment you are receiving until after the study is complete, unless there's a medical need to find out.
How long will I be in the study?
You will take the study medication for 12 weeks, but your full involvement, including follow-up appointments, will be longer. The study team will provide the exact timeline.
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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