A Phase 1b, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Safety, Engraftment, and Initial Signs of Clinical Activity of MB310 in Patients with Active, Mild to Moderate Ulcerative Colitis (COMPOSER-1)
This study, called COMPOSER-1, is an early and important step in developing a new treatment, MB310, for ulcerative colitis. Ulcerative colitis is a long-term condition that causes inflammation and ulcers in the large intestine. Researchers want to see if MB310 is safe for people to use and how well their bodies accept it. They will also be carefully looking for any first signs that the treatment might improve symptoms in adults with active, mild to moderate ulcerative colitis. This trial is ‘randomized,’ meaning some participants will get the new treatment and others will get a placebo (a dummy treatment), to fairly compare the effects. It’s also ‘double-blind,’ which means neither the patients nor the doctors will know who is receiving which treatment, again to ensure fairness.
At a glance
What is this study about?
This study is a very early step in researching a potential new treatment called MB310 for adults who have ulcerative colitis. Ulcerative colitis is a long-term condition that causes inflammation and sores in the lining of your large intestine. This can lead to symptoms like tummy pain, diarrhoea, and needing to go to the toilet urgently. We don't yet have enough information about this new treatment, MB310, so this study is designed to gather essential early details.
The main goals of this study are to carefully check if MB310 is safe for people to use and how well it settles in the body. The research team will also be looking for any early hints that the treatment might be helpful in reducing the symptoms of mild to moderate ulcerative colitis. It's important to remember that because this is an early study, we are still learning a lot about MB310.
To make sure the results are as fair and accurate as possible, this study is set up in a specific way. It's 'randomized,' which means a computer will decide whether you receive the new treatment MB310 or a 'placebo' (a treatment that looks the same but contains no active medicine). It's also 'double-blind,' which means neither you nor your study doctor will know whether you are getting MB310 or the placebo. This helps to ensure that everyone is treated fairly and that any observed effects are truly due to the treatment, not expectations.
Key takeaways
- This is an early study for a new ulcerative colitis treatment, MB310.
- The main goals are to check safety and how the treatment works in the body.
- It will also look for early signs of improvement in symptoms.
- Participants will either receive MB310 or a placebo, and neither they nor their doctor will know which.
- The study is for adults aged 18 and over with mild to moderate ulcerative colitis.
Who may be eligible?
To join this study, you must be at least 18 years old. People of all genders can take part. The study is specifically looking for individuals who have active ulcerative colitis that is considered to be mild to moderate in severity, meaning your symptoms are present but not extremely severe.
The study team will need to check your medical history and current health carefully to make sure you are a good fit and that taking part would be safe for you. They will consider your general health to ensure you can safely participate in all parts of the study.
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 ulcerative colitis?
- Is your ulcerative colitis currently active, and considered mild to moderate?
- Are you able to attend regular study visits and follow study procedures?
What does participation involve?
If you decide to take part in this study, you will have regular visits to the study clinic. These visits will involve various assessments such as physical examinations, blood tests, and possibly other tests to monitor your health and how the treatment is affecting you. You will receive either the new treatment, MB310, or a placebo, which looks identical but contains no active medicine. The study will last for a certain period, which will be explained to you in detail. After you finish receiving the treatment, there will also be follow-up visits to continue monitoring your health and any effects of the study medicine.
Potential risks and benefits
Locations (4)
- —UnverifiedAustria
- —UnverifiedPoland
- —UnverifiedBulgaria
- —UnverifiedSpain
Common questions
What is a 'Phase 1b' study?
This is an early study to check if a new treatment is safe for people and how it acts in the body. It also looks for the first signs that it might be helpful.
What does 'placebo-controlled' mean?
It means some participants will receive the new treatment, and others will receive a 'dummy' treatment that looks the same but has no medicine, to help compare the effects fairly.
What does 'double-blind' mean?
It means neither you nor your doctor will know if you are getting the new treatment or the placebo. This helps make the study results as unbiased as possible.
Will I know if I'm getting the actual study drug?
During the study, no, neither you nor your study doctor will know. This helps ensure fair results. Afterwards, you may be told which treatment you received.
What is 'engraftment'?
In this context, it refers to how well the new treatment 'settles in' or is accepted by your body and starts to work as intended.
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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