A randomized, double-blind, placebo-controlled, multicenter phase III study to evaluate the efficacy and safety of ABX464 once daily for induction treatment in subjects with moderately to severely active ulcerative colitis
This study is for adults, 18 or older, who have moderate to severe ulcerative colitis. It's looking into a new medicine called ABX464 to see how well it works and if it's safe. Some participants will receive ABX464, and others will receive a dummy medicine called a placebo. The researchers want to find out if ABX464 can help reduce symptoms like tummy pain and urgent bowel movements, and if it can help the gut lining heal. They will compare these results between the group taking the new medicine and the group taking the placebo. This is a crucial step in understanding if ABX464 could be a future treatment option for ulcerative colitis.
At a glance
What is this study about?
Ulcerative colitis is a long-term condition where the lining of the large bowel and rectum becomes inflamed. This can cause symptoms like tummy pain, bloody diarrhoea, and tiredness. For some people, these symptoms can be quite severe and significantly affect their daily lives. Current treatments aim to reduce this inflammation and manage symptoms, but they don't work for everyone, and new options are always being explored.
This study, called a Phase III trial, is a very important step in testing a new medicine called ABX464. Think of it like the final stage of testing a new product before it's potentially made widely available. We want to see if ABX464 can help people with moderate to severe ulcerative colitis feel better and if it can make a real difference to the inflammation in their gut.
To do this fairly, some people in the study will get ABX464, and others will get a 'dummy' medicine, called a placebo. This helps us compare the effects of the new medicine accurately. Neither you nor your doctor will know which you are receiving. The main goal is to see if taking ABX464 for eight weeks leads to improvements in symptoms and healing of the gut lining, which doctors can check with a procedure called an endoscopy. We'll also be closely watching for any side effects to make sure the medicine is safe.
Key takeaways
- This study is for adults (18+) with moderate to severe ulcerative colitis.
- It's testing a new medicine, ABX464, against a dummy pill (placebo).
- The goal is to see if ABX464 improves symptoms and gut healing.
- Participation involves taking daily capsules and attending clinic visits for 8 weeks.
- All health changes and side effects will be closely watched.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. There's no upper age limit, meaning older adults can also take part. We're looking for individuals who have been diagnosed with ulcerative colitis and whose condition is currently considered moderate to severe. This means your symptoms are significantly affecting you, even if you are already on some treatment.
Both men and women are welcome to participate. The study will carefully review your full medical history and current health to make sure it's safe and appropriate for you to join. For example, if you have other serious health problems, or if you are pregnant or breastfeeding, the study might not be suitable.
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 ulcerative colitis?
- Are your ulcerative colitis symptoms currently moderate to severe?
- Are you able to attend regular clinic appointments?
What does participation involve?
If you decide to take part, you'll be given either the study medicine (ABX464) or a dummy medicine (placebo) as a daily capsule. During the study, you'll have regular visits to the clinic where the study team will monitor your health. These visits will involve check-ups, blood tests, and sometimes other tests like an endoscopy, which allows doctors to look inside your bowel. These tests help us understand how you're responding to the treatment and to keep an eye on your general health.
You'll be asked to keep a record of your symptoms and how you're feeling. The initial treatment period, where the main comparisons are made, lasts for eight weeks. After this, there might be options for continued treatment depending on the study design and your response. The study team will explain the full schedule of visits, what each visit involves, and the total expected duration of your involvement.
Potential risks and benefits
Locations (13)
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedPoland
- —UnverifiedBelgium
- —UnverifiedAustria
- —UnverifiedBulgaria
- —UnverifiedCzechia
- —UnverifiedGreece
- —UnverifiedHungary
- —UnverifiedPortugal
Common questions
What is ABX464?
ABX464 is a new medicine being tested to see if it can help people with ulcerative colitis by reducing inflammation.
Will I know if I'm getting the real medicine or a dummy pill?
No, neither you nor your doctor will know if you are receiving ABX464 or the dummy medicine (placebo). This helps make the study results fair.
How long will I be involved in the study?
The main treatment period for comparing the medicine to placebo is 8 weeks. The full duration of your participation, including follow-up, will be explained by the study team.
What kind of tests will I have?
You'll have regular check-ups, blood tests, and potentially an endoscopy to look at your bowel, to monitor your health and how the treatment is working.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason, and this will not affect your usual 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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