A multinational, multicenter extension study to investigate the long-term safety, tolerability and efficacy of balinatunfib in adults with Crohn’s disease or ulcerative colitis
This research study is for adults who have either Crohn's disease or ulcerative colitis. It’s looking at a new treatment called balinatunfib. The main goal is to understand the long-term safety of this medicine, including any side effects that might happen. Researchers will also check to see if participants tolerate the medication well over time. Additionally, the study aims to see how effective balinatunfib is in managing these conditions, such as improving gut healing and reducing symptoms. This is a Phase II study, which means it’s still in the earlier stages of testing, focusing on finding the right dose and further exploring its effects in conditions like yours.
At a glance
What is this study about?
This study is investigating a new medicine called balinatunfib for adults living with inflammatory bowel diseases such as Crohn's disease or ulcerative colitis. These are ongoing conditions that cause inflammation in your gut. Because balinatunfib is a newer treatment, this study is designed to gather more information about how it works over a longer period.
The main purpose of this study is to closely monitor the safety of balinatunfib. This means researchers will be carefully looking for any unwanted side effects that might occur while people are taking the medicine. They also want to understand if people can comfortably take the medicine for an extended time. This type of information is crucial for understanding how helpful and manageable a new treatment might be.
Beyond safety, the study will also explore how effective balinatunfib is in treating Crohn's disease and ulcerative colitis. For example, they will check if the medicine helps the gut to heal and if it reduces common symptoms. By conducting these types of studies, doctors hope to find better ways to manage these challenging conditions and improve the quality of life for people affected by them.
Key takeaways
- This study is testing a new medicine called balinatunfib for Crohn's disease and ulcerative colitis.
- The main goals are to check the medicine's safety, side effects, and how well people tolerate it over time.
- It also looks at whether the treatment improves gut healing and symptoms.
- Only adults aged 18 and older with a confirmed diagnosis of Crohn's or ulcerative colitis can join.
- Taking part means regular check-ups and taking the study medicine.
- You can stop participating at any time if you change your mind.
Who may be eligible?
This study is open to adults aged 18 and over. There is no upper age limit, meaning older adults can also take part. Both men and women are welcome to participate in this research.
To be eligible, you must have a confirmed diagnosis of either Crohn's disease or ulcerative colitis. The healthcare team running the study will check your medical history to make sure you meet all the specific requirements for participation.
It's important to remember that even if you have Crohn's disease or ulcerative colitis and are over 18, there might be other medical reasons or treatments you are currently on that could affect your ability to join. The study team will discuss all of these details with you.
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?
- Do you have a diagnosis of ulcerative colitis?
- Are you able to attend regular clinic visits?
- Are you willing to take a new study medicine?
What does participation involve?
If you decide to take part in this study, you would primarily be taking the study medication, balinatunfib. You would also have regular visits to the clinic, where the study team will closely monitor your health. These visits will include checks for any side effects, and they might involve blood tests, physical examinations, and possibly tests to look at your gut health, such as endoscopies. The study will assess how you are feeling and how your condition is responding to the treatment over time. The exact number of visits, tests, and the total duration would be explained in detail by the study team before you decide to join.
Potential risks and benefits
Locations (14)
- —UnverifiedBelgium
- —UnverifiedGermany
- —UnverifiedCzechia
- —UnverifiedNetherlands
- —UnverifiedSpain
- —UnverifiedAustria
- —UnverifiedItaly
- —UnverifiedGreece
- —UnverifiedCroatia
- —UnverifiedBulgaria
- —UnverifiedPoland
- —UnverifiedFrance
Common questions
What is balinatunfib?
Balinatunfib is a new medicine being tested to treat Crohn's disease and ulcerative colitis. We are still learning about how it works.
What is a 'Phase II' study?
A Phase II study is an early stage of clinical research. It mainly focuses on checking the safety of a new medicine and seeing if it has any effects on the condition.
Will I definitely get the new medicine?
In this specific study, all participants will receive balinatunfib. There is also a comparison group receiving a treatment that isn't exactly the same as balinatunfib but is used for comparison.
What kind of checks will I have?
You'll have regular health checks, including looking for side effects and assessing your gut health and symptoms over time.
How long will I be in the study?
The study is designed to look at the long-term effects. The exact duration will be explained by the study team, but it will involve ongoing monitoring.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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