Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects with Moderately to Severely Active Ulcerative Colitis

This study is looking at a new medicine called VTX002 for adults who have ulcerative colitis that is moderate to severe. Ulcerative colitis is a long-term condition where the lining of the bowel becomes inflamed. The main goal is to see if VTX002 can help people feel much better and improve their condition after 13 weeks, compared to those taking a placebo (a dummy pill with no medicine). Researchers will also check if the medicine helps the bowel lining heal and reduces symptoms. This is an important step to find new and better treatments for ulcerative colitis.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Oppilan Pharma Limited

Enrolment target

132

Start

20 Sep 2024

Moderately to Severely Active Ulcerative Colitis

What is this study about?

This study is all about finding new ways to help people living with ulcerative colitis. Ulcerative colitis is a type of inflammatory bowel disease where the large intestine (colon) and rectum become inflamed, leading to symptoms like tummy pain, diarrhoea, and needing to go to the toilet urgently. When it's described as 'moderate to severe', it means these symptoms are having a big impact on a person's daily life.

The new medicine being tested in this study is called VTX002. The research team wants to understand how well VTX002 works to improve people's symptoms and their overall health. They also want to make sure it's safe to use. You might have noticed other names like 'tamuzimod' – these all refer to the same new medicine being investigated.

This study compares VTX002 to a 'placebo', which is a pill that looks exactly like the medicine but doesn't contain any active ingredient. Some people in the study will get VTX002 and others will get the placebo. This helps the researchers truly understand if any improvements are due to the new medicine or something else. The main thing they'll look at is how many people have their ulcerative colitis go into 'remission' – meaning their symptoms significantly improve or disappear – after 13 weeks.

Key takeaways

Tests a new medicine (VTX002) for moderate to severe ulcerative colitis.
Compares VTX002 to a dummy pill (placebo) to see if it works.
Aims to achieve 'clinical remission' (significant symptom improvement) after 13 weeks.
Open to adults aged 18 and over, both men and women.
Requires regular clinic visits for checks, tests, and symptom assessments.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women can take part. You need to have been diagnosed with ulcerative colitis, and it should be active – meaning you're currently experiencing symptoms and your condition is moderate to severe.

There might be other reasons why you can't join, even if you meet these basic criteria. For example, certain other health conditions or medicines you're taking could mean this study isn't right for you. This is to make sure the study is safe for everyone involved and that the results are as clear as possible.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with ulcerative colitis?
Is your ulcerative colitis currently active and considered moderate to severe?
Are you able to attend regular clinic appointments for the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would be randomly assigned to either receive the new medicine (VTX002) or a dummy pill (placebo). You wouldn't know which one you're getting, and neither would your study doctor. You would take these tablets as instructed.

Over the course of the study, you would have several visits to the study clinic. These visits would involve various checks, such as physical exams, blood tests, and possibly endoscopies (a procedure to look inside your bowel) to see how your ulcerative colitis is responding. You would also be asked about your symptoms and how you are generally feeling. The overall duration of your participation in this study, including follow-up, would be made clear to you by the study team.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as receiving a new investigational treatment that might help your ulcerative colitis. However, there's no guarantee it will work for you, and it's also possible you could receive the placebo. There might be side effects from the medicine, some of which could be unknown at this stage. All procedures, like blood tests, also carry small risks. You will be closely monitored by the study team. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

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Germany
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Czechia
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Slovakia
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Hungary
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Bulgaria
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Poland
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Lithuania
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Italy

Common questions

What is VTX002?

VTX002 is a new medicine being tested to see if it can help people with moderate to severe ulcerative colitis.

What is a 'placebo'?

A placebo is a dummy pill that looks like the real medicine but doesn't contain any active ingredients. It helps researchers compare if the new medicine is truly working.

How long does the study last?

The main part of the study assessing how well the treatment works is 13 weeks. The full length of your participation, including follow-up, will be explained by the study team.

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 it helps make the study results fair and accurate.

What does 'clinical remission' mean?

Clinical remission means that your symptoms have significantly improved or have largely gone away, based on a special scoring system used by doctors.