Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Orismilast for the treatment of moderate to severe ulcerative colitis

This UK-based study is exploring a new medication called Orismilast for adults living with moderate to severe ulcerative colitis. Ulcerative colitis is a long-term condition that causes inflammation and sores in the lining of the large intestine. As a Phase II trial, this research is focused on finding out if Orismilast is safe and effective enough to continue into larger studies. Researchers will be carefully checking if the medicine helps improve symptoms like trips to the toilet and bleeding, aiming for a significant reduction in how severe the condition is. They will also look at how patients’ physical and mental well-being changes, and keep a close eye on any side effects. The goal is to see if Orismilast could be a helpful new treatment option in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Hvidovre Hospital

Enrolment target

Start

30 Jun 2023

ulcerative colitis

What is this study about?

This clinical trial is investigating a new medication called Orismilast for people who have moderate to severe ulcerative colitis. Ulcerative colitis is a long-term condition where the lining of the large intestine (bowel) becomes inflamed and develops small sores, called ulcers. This can cause symptoms like tummy pain, bloody stools, and needing to go to the toilet urgently and frequently. Moderate to severe means that these symptoms are quite noticeable and can significantly affect daily life.

The main aim of this study is to see if Orismilast can help reduce the symptoms of ulcerative colitis and lead to 'clinical remission'. This means reducing the severity of your symptoms so much that it feels like the condition is much less active or isn't bothering you. The study will pay close attention to improvements in symptoms like how often you need to go to the toilet and any bleeding.

This is a Phase II trial, which means it's an earlier stage of research. Before new medicines can be approved for widespread use, they have to go through several phases of testing. Phase I usually checks safety in a small group of healthy people, while Phase II involves a larger group of people who have the condition. In this phase, researchers are trying to find the right dose and see if the medicine works well enough to be tested in even larger studies (Phase III) later on. They're also carefully monitoring for any side effects.

Key takeaways

This study is testing a new medicine called Orismilast for moderate to severe ulcerative colitis.
It's a Phase II trial, looking at how well the medicine works and if it's safe.
The main goal is to see if Orismilast can significantly reduce symptoms like inflammation and discomfort.
Adults aged 18 and older with active ulcerative colitis are being invited to participate.
Participants will receive close medical monitoring and care during the 12-week study period.

Who may be eligible?

This study is looking for adults aged 18 and over who have been diagnosed with moderate to severe ulcerative colitis. There are no restrictions based on gender, so both men and women can take part.

To be considered for the study, your ulcerative colitis symptoms must be at a certain level, meaning they are active enough to be classed as moderate to severe. The doctors running the study will check your medical history and current health to make sure that taking part is suitable and safe for you.

There might be some reasons why you wouldn't be able to join, such as other health conditions you have, or other medications you are currently taking. The research team will discuss all the requirements with you in detail to see if this study is a good fit.

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?
Are your ulcerative colitis symptoms currently considered moderate to severe by your doctor?
Are you able to attend regular clinic visits for 12 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the study medication, Orismilast, to take. You will have regular visits to the clinic over a period of 12 weeks. During these visits, the research team will carry out various assessments. This includes checking your symptoms, taking blood tests to measure certain markers of inflammation, and you might also be asked to provide stool samples. You will also complete questionnaires about your general well-being and any symptoms of anxiety or depression. The doctors will also likely perform an endoscopy to look at the inside of your bowel. Throughout the study, the research team will monitor you closely for any side effects or changes in your health. The total duration of active treatment and monitoring for this part of the study is 12 weeks.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as gaining access to a new treatment like Orismilast before it's widely available, and receiving close medical care and monitoring from experienced healthcare professionals. However, there are also potential risks; for example, the new medicine might not work for you, or you could experience side effects. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where the lining of your large intestine (bowel) becomes inflamed and develops small sores, causing symptoms like tummy pain and urgent trips to the toilet.

What is Orismilast?

Orismilast is the name of the new medicine being tested in this study to see if it can help people with moderate to severe ulcerative colitis.

What does 'Phase II trial' mean?

Phase II means this is an earlier stage of research where doctors are checking if the new medicine is safe and if it works well enough to continue into bigger studies.

How long will the study last for me?

The main part of the study where you take the medication and have regular check-ups will last for 12 weeks.

Will I know if I'm getting the active drug or a placebo?

In most trials like this, you will not know if you're getting the active drug or a dummy pill (placebo) to ensure fair results. The research team can explain more about this specific trial design.