RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Evaluate the Activity, and Safety of Vixarelimab in Participants With Moderate to Severe Active Ulcerative Colitis

This research study is about a new medicine called Vixarelimab for people living with moderate to severe ulcerative colitis. Ulcerative colitis is a long-term condition that causes inflammation and ulcers in the large intestine. The main goal of this study is to understand how Vixarelimab works inside the body, specifically in the gut, and to check if it's safe for patients. Researchers often do these kinds of studies in phases. This particular study is in its early stages (Phase 1 and Phase 2), meaning they are still learning a lot about the drug. They hope to find out if Vixarelimab could be an effective new treatment, especially for those whose current treatments haven't worked well enough. Participants will be aged 18 and over, and both men and women can take part.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Genentech, Inc.

Enrolment target

Start

31 Mar 2025

Estimated completion

16 Aug 2026

Moderate to Severe Ulcerative Colitis

What is this study about?

This study is testing a new medicine called Vixarelimab for people who have ulcerative colitis. Ulcerative colitis is a type of inflammatory bowel disease (IBD) that affects the large intestine. It causes inflammation and sores (ulcers) in the lining of your gut, leading to symptoms like tummy pain, bloody stools, and tiredness. When doctors say 'moderate to severe,' it means your symptoms are quite noticeable and affect your daily life.

The main aim of this research is to understand how Vixarelimab works inside the body. Specifically, the researchers want to see how it affects the gut in people with ulcerative colitis. This is an important step in developing new medicines. They also want to make sure the medicine is safe and doesn't cause too many side effects.

This study is in its early stages (Phase 1 and Phase 2). This means it's one of the first times this medicine has been given to a group of patients to learn more about it. If these early studies show promising results, the medicine can then move on to larger studies. The hope is that Vixarelimab could offer a new treatment option for people with ulcerative colitis, especially if other treatments haven't been as effective as hoped.

Key takeaways

This study is for adults (18+) with moderate to severe ulcerative colitis.
It's testing a new medicine called Vixarelimab to see how it works and if it's safe.
It's mainly for people whose current treatments haven't been fully effective.
Participation involves regular clinic visits for checks and receiving the study medicine.
There are potential benefits (new treatment) and risks (side effects).
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. You must have been diagnosed with ulcerative colitis at least three months ago, and your condition needs to be considered 'moderately to severely active' by your doctor. This study is mainly for people whose current treatments, whether they are standard medicines or newer 'advanced' therapies, haven't fully helped manage their ulcerative colitis.

However, there are reasons why you might not be able to join. For example, if your doctor suspects you have Crohn's disease or another similar bowel condition instead of ulcerative colitis, this study wouldn't be right for you. Also, if you’ve had surgery to remove your large intestine (a 'colectomy') or if you've recently used certain types of medication called 'JAK inhibitors,' you wouldn't be able to take part.

It's important to remember that detailed checks will be done by the study team to make sure it's safe and appropriate for you to participate.

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 for at least 3 months?
Is your ulcerative colitis currently moderate to severe?
Have your previous treatments for ulcerative colitis not worked well enough?
Have you NOT had surgery to remove your large intestine?
Do you NOT have Crohn's disease or other similar bowel conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to check if you meet all the requirements. This could involve physical exams, blood tests, and reviewing your medical history. If you're eligible, you would receive the study medicine, Vixarelimab, which would be given at specific times over a set period. The study team would advise you on how the medicine is given (e.g., as an injection or infusion).

Throughout the study, you would have regular visits to the clinic or hospital. These visits are important for monitoring your health, checking how the medicine is working, and looking out for any side effects. They might include more blood tests, physical examinations, and questions about how you're feeling and your symptoms. The exact number and timing of these visits, as well as the total length of your participation, would be clearly explained by the study team before you agree to join.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might gain access to a new treatment, Vixarelimab, that isn't widely available yet and could potentially help your ulcerative colitis symptoms if other treatments haven't worked well. However, there's always a chance the treatment might not work for you, or it could cause side effects. These side effects could be mild or, in some cases, more serious. The research team will carefully explain all known risks before you make a decision. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Charité Research Organisation GmbH
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is Vixarelimab?

Vixarelimab is a new medicine being tested for people with ulcerative colitis. Researchers want to see how it works and if it's safe.

What does 'Phase 1 and 2' study mean?

These are early stages of drug testing. Phase 1 checks safety and dosage in a small group, and Phase 2 looks at effectiveness and side effects in a larger group.

Will I definitely get the new medicine if I join?

In some studies, you might get the new medicine, or you might get a dummy treatment (placebo) or another approved treatment. The study team will explain what applies here.

How long will the study last if I join?

The exact length of your participation will be explained by the study team. It usually involves several months of treatment and follow-up.

Can I leave the study at any time?

Yes, you are free to leave the study at any point without it affecting your future medical care.

How to find out more

Reference Study ID Number: GA45735 https://forpatients.roche.com/

global-roche-genentech-trials@gene.com 888-662-6728 (U.S.) Official trial record

Always speak to your GP or specialist before deciding to take part in a study.