Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase II, Multicenter Induction Study with an Active Treatment Extension to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Patients with Moderate to Severe Ulcerative Colitis

This research study is for adults in the UK who have ulcerative colitis that is moderate to severe. It's looking at a new medicine called Vixarelimab. Researchers want to understand if Vixarelimab can help people feel better by reducing symptoms like frequent bowel movements and bleeding, and if it can improve the inflammation in the gut. They will also be carefully checking for any side effects and how the body processes the new drug. Patients will either receive Vixarelimab or a dummy drug (placebo) first, and then some may continue on Vixarelimab. Other standard treatments for ulcerative colitis might also be part of the study for comparison.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Genentech Inc.

Enrolment target

138

Start

23 Apr 2024

Ulcerative Colitis (UC)

What is this study about?

This study is a research project designed to explore a new potential treatment, Vixarelimab, for adults living with moderate to severe ulcerative colitis. Ulcerative colitis is a long-term condition where the lining of the large bowel and rectum becomes inflamed, causing symptoms like tummy pain, bloody stools, and frequent trips to the toilet. Current treatments aim to reduce this inflammation and help people feel better.

In this study, researchers are particularly interested in seeing if Vixarelimab can lead to what's called 'clinical remission' after 12 weeks. This means a significant improvement in symptoms, with fewer bowel movements, no or very little rectal bleeding, and reduced inflammation visible inside the bowel during an examination. They will also look at how much symptoms improve overall and if the inside of the bowel looks healthier.

Another very important part of the study is to understand the safety of Vixarelimab. This means carefully tracking any side effects or unwanted reactions patients might experience. The study will also examine how the body handles Vixarelimab, including how much of the drug is in the blood at different times and if the body develops antibodies against it. This helps researchers understand the best way to give the medicine in the future.

Key takeaways

This study is for adults with moderate to severe ulcerative colitis.
It's testing a new drug called Vixarelimab.
The main goal is to see if Vixarelimab can improve symptoms and reduce inflammation.
Researchers will also carefully monitor for any side effects.
Participants will have regular medical checks and may receive Vixarelimab or a placebo.

Who may be eligible?

This study is looking for adult volunteers, aged 18 years or older, who have been diagnosed with moderate to severe ulcerative colitis. The study is open to both men and women.

To be considered for the study, your ulcerative colitis needs to be active and causing moderate to severe symptoms. There will be specific medical checks to make sure your condition fits the study's requirements and that you are healthy enough to take part. For example, certain other medical conditions or medications might mean you can't join.

The research team will carry out a thorough assessment to determine if this study is suitable for you. It's important to discuss your full medical history with them so they can ensure your safety and that the 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?
Have you been diagnosed with ulcerative colitis?
Is your ulcerative colitis currently moderate to severe?
Are you open to regular clinic visits and medical tests?
Are you comfortable with the possibility of receiving a placebo initially?

Answer every question to see your result.

What does participation involve?

Taking part in this study will involve regular visits to the study clinic over a period of time. During these visits, you will have medical examinations, blood tests, and possibly other tests like endoscopies (where a small camera looks inside your bowel) to check your progress and the condition of your gut. You will be given either the new drug, Vixarelimab, or a placebo (a dummy drug that looks like the active treatment but contains no medicine) for an initial period. After this, depending on your progress, you may continue to receive Vixarelimab.

You will need to keep a record of your symptoms at home, such as your bowel movements and any bleeding. The research team will be there to guide you through all the steps and answer any questions. The total duration of your participation in the study will depend on how you respond to the treatment and the study design, but it will be explained in detail before you agree to join.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available, and close medical monitoring. However, there are potential risks, including side effects from the study medication, which may or may not be known yet. You might also receive a placebo, meaning you wouldn't get the active treatment in the initial phase. It's crucial to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

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

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Unverified
Belgium
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Unverified
Germany
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Unverified
France
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Unverified
Italy
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Unverified
Czechia
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Unverified
Greece
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Unverified
Poland

Common questions

What is Vixarelimab?

Vixarelimab is a new drug being tested for ulcerative colitis to see if it can reduce inflammation and symptoms.

What does 'clinical remission' mean in this study?

It means a significant improvement in symptoms, low frequency of bowel movements, no or very little rectal bleeding, and reduced inflammation in the gut.

Will I definitely get the new drug?

Initially, you might receive Vixarelimab or a placebo (dummy drug). Some participants may then go on to receive Vixarelimab.

What are the common symptoms of ulcerative colitis?

Common symptoms include tummy pain, blood in your poo, and needing to go to the toilet urgently and often.

Can I stop participating in the study at any time?

Yes, you have the right to leave the study at any point, and this will not affect your future medical care.