A Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects with Moderately to Severely Active Crohn’s Disease
This research study is for people in the UK who have moderately to severely active Crohn's disease. It's an early-stage (Phase 2a) clinical trial, which means we're carefully testing a new medication called tulisokibart for the first time in a group of patients. The main goals are to check if the medicine is safe and if it helps improve the disease. We'll be looking at side effects and how much the inflammation in the gut improves. We're also interested in how the body processes the medication. By participating, you could help us learn more about potential new treatments for Crohn's disease.
At a glance
What is this study about?
This study is all about finding a new way to help people living with Crohn's disease. Crohn's is a long-term condition that causes inflammation in the digestive system, leading to symptoms like tummy pain, diarrhoea, and tiredness. We're investigating a new medicine called tulisokibart. This is an early phase of research, which means we're taking the first steps to understand how it works in people. We want to find out if it's safe to use and if it can help reduce the inflammation and symptoms of Crohn's disease.
The main things we'll be looking at are safety – that's paramount. We'll be carefully monitoring for any side effects and how well people tolerate the medicine. We'll also be checking to see if there's an improvement in the gut lining, which doctors can see during a procedure called an endoscopy. This will help us understand if the medicine is making a real difference to the disease itself, not just the symptoms.
Beyond these main points, we'll also be exploring other important aspects. This includes looking at whether people feel better in terms of their symptoms, if certain markers in their blood or stool that show inflammation go down, and how the medicine behaves once it's in the body. All this information helps us build a complete picture of tulisokibart and its potential as a future treatment for Crohn's disease.
Key takeaways
- This study is testing a new medicine called tulisokibart for Crohn's disease.
- It's an early-stage study focused on safety and if the medicine helps improve inflammation.
- Participants will receive the active study medicine, not a placebo.
- The study lasts about 12 weeks with regular check-ups and monitoring.
- It helps researchers understand potential new treatments for Crohn's.
Who may be eligible?
To join this study, people need to be at least 18 years old and have been diagnosed with moderately to severely active Crohn's disease. This means your Crohn's isn't fully under control and is causing significant symptoms.
There will be specific criteria that your doctor will discuss with you to make sure the study is a safe and appropriate option for your individual health situation. For example, they'll check your medical history and current health status to ensure you meet all the necessary requirements.
If you're interested, your doctor can help determine if this study is suitable for you. It's important to remember that not everyone with Crohn's disease will be able to join, as studies need to be very specific about who can take part to ensure safety and clear results.
- Are you 18 years old or older?
- Have you been diagnosed with Crohn's disease?
- Is your Crohn's disease currently active and causing moderate to severe symptoms?
- Are you able to attend regular clinic visits and appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would receive the study medication, tulisokibart. This is an 'open-label' study, which means both you and your study doctor will know you are receiving the active medicine. You would have several visits to the study clinic over a period of about 12 weeks. During these visits, the study team would perform various assessments. This includes regular check-ups, blood tests, and sometimes stool samples to monitor your health and how the medicine is working. You might also have an endoscopy at the start and end of the study to look at your gut inflammation. The total duration of active participation in the study is approximately 12 weeks, with follow-up appointments and continued monitoring.
Potential risks and benefits
Locations (3)
- —France
- —Poland
- —Czechia
Common questions
What is Crohn's disease?
Crohn's disease is a condition that causes long-lasting inflammation in your digestive system, leading to symptoms like stomach pain, diarrhoea, and tiredness.
What is tulisokibart?
Tulisokibart is the name of the new medicine being tested in this study to see if it can help people with Crohn's disease.
What does 'Phase 2a' mean?
Phase 2a means this is an early stage of testing. We're carefully looking at the new medicine's safety and if it shows encouraging signs of helping people with Crohn's disease.
Will I know if I'm getting the actual medicine?
Yes, this is an 'open-label' study, which means both you and your doctor will know you are receiving the new medicine, tulisokibart.
How long will I be in the study?
Your active participation in this study, including visits and treatments, will last for about 12 weeks.
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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