Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients with Mild-to-Moderate Ulcerative Colitis
This research study is testing a new medication, VE202, for adults in the UK who have a type of inflammatory bowel disease called mild to moderate ulcerative colitis. Researchers want to find out if VE202 can reduce the inflammation and symptoms often seen in the bowel. They are also carefully watching for any side effects to make sure the medicine is safe. Some people will receive VE202, while others will get a placebo (a dummy pill that looks the same but contains no active medicine). This helps researchers understand the true effects of VE202. The study is in an early stage, called Phase 2, which means it's one of the first times the medicine is being tested in a larger group of patients.
At a glance
What is this study about?
This study is all about trying to find a new and better way to help people with mild to moderate ulcerative colitis. Ulcerative colitis is a long-term condition where the lining of your large intestine (bowel) becomes inflamed and develops tiny ulcers. This can cause symptoms like tummy pain, diarrhoea, and needing to go to the toilet urgently. The new medicine being tested, VE202, is hoped to reduce this inflammation and make you feel better.
To find out if VE202 works and is safe, the researchers will compare it to a 'placebo'. A placebo is like a dummy pill that looks exactly like the real medicine but doesn't have any active ingredients. This is a common and important way that medical studies are done, as it helps doctors understand if any changes are truly due to the new medicine or just to other factors. Neither you nor your study doctor will know if you are receiving VE202 or the placebo, which helps keep the results fair and unbiased.
This is a Phase 2 study, meaning it's an earlier step in developing new medicines. It focuses on exploring whether the medicine works as expected and identifying the best dose, as well as keeping a very close eye on any side effects. If this stage is successful, it could lead to larger studies and potentially a new treatment option for people living with ulcerative colitis.
Key takeaways
- It's a study for adults aged 18+ with mild to moderate ulcerative colitis.
- It's testing a new medicine called VE202 against a dummy pill (placebo).
- The study aims to see if VE202 improves bowel inflammation and is safe.
- Participation involves taking capsules and attending clinic visits for about 8 weeks.
- You won't know if you're getting the active medicine or the placebo.
Who may be eligible?
This study is open to adults aged 18 and over, of any gender. If you have mild to moderate ulcerative colitis, you might be able to take part.
The research team will need to check your medical history carefully to make sure the study is right for you and safe. This will involve looking at your specific diagnosis, any other health conditions you might have, and medications you are currently taking.
They will also do some tests, including checking the inflammation in your bowel using a special camera (called a flexible sigmoidoscopy), to confirm that your ulcerative colitis is at the right level for this study. If you meet all these specific health criteria, you may be invited 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 mild to moderate ulcerative colitis?
- Are you able to attend regular clinic visits for about 8 weeks?
- Are you willing to undergo medical tests, including bowel examinations?
- Are you currently not pregnant or planning to become pregnant during the study period?
What does participation involve?
If you decide to take part, you will be given study medication, which might be VE202 or a placebo, in special enteric-coated capsules that protect the medicine until it reaches your bowel. You would take this medication regularly as instructed by the study team.
Over the course of the study, you would have several visits to the clinic for check-ups. These visits will involve various assessments, including physical examinations, blood tests, and repeat flexible sigmoidoscopy to see how your bowel inflammation is changing. The main part of the study will last about 56 days (roughly 8 weeks), with follow-up appointments to ensure your health is monitored. The research team will track any side effects very closely throughout your participation.
Potential risks and benefits
Locations (6)
- —UnverifiedNetherlands
- —UnverifiedCzechia
- —UnverifiedHungary
- —UnverifiedBulgaria
- —UnverifiedLithuania
- —UnverifiedPoland
Common questions
What is ulcerative colitis?
It's a long-term condition where the lining of your large intestine becomes inflamed and develops small ulcers, leading to symptoms like tummy pain and urgent diarrhoea.
What does 'placebo-controlled' mean?
It means some people get the active medicine, while others get a dummy pill with no active ingredients. This helps researchers understand the real effect of the medicine.
What is a Phase 2 study?
It's an early stage of testing a new medicine in a smaller group of patients to see if it works and to check for common side effects.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know. This is called 'double-blind' and helps keep the study fair and unbiased.
Can I leave the study if I change my mind?
Yes, you can withdraw from the study at any time, for any reason, and it will not affect your regular 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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