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A study to evaluate the efficacy and safety of vixarelimab in patients with moderate to severe ulcerative colitis

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals living with Ulcerative Colitis, a long-term condition that causes inflammation and sores in the lining of the large intestine. The purpose of the study is to evaluate the efficacy of vixarelimab compared to a placebo in achieving clinical remission, which is a state where symptoms of the disease are significantly reduced or gone. Participants in the study may also be taking other medications as part of their usual care, such as azathioprine, adalimumab, methotrexate, golimumab, infliximab, mercaptopurine, corticosteroids, or aminosalicylates.

The study consists of an initial phase to see how well the treatment works to control symptoms, followed by an extension period to continue monitoring the effects. During the study, medical professionals will monitor the levels of vixarelimab in the blood and check for anti-drug antibodies, which are substances the body might create in response to a medication. The course of the study involves regular assessments to observe changes in symptoms and the condition of the intestinal lining.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Induction phase

    During the first 12 weeks, vixarelimab or a placebo (a substance with no active medicine) is administered via subcutaneous injection, which is an injection under the skin.

    The goal of this phase is to achieve clinical remission, meaning the reduction of symptoms of ulcerative colitis, an inflammatory condition of the large intestine.

  2. Step 2

    Assessment at week 12

    At the end of week 12, the effectiveness of the treatment is evaluated based on stool frequency, rectal bleeding, and endoscopy results.

    endoscopy is a procedure where a doctor uses a small camera to look inside the intestine to check for healing.

  3. Step 3

    Treatment extension

    After the initial 12 weeks, an active treatment extension phase is provided to continue the evaluation of the medicine's effects and safety.

Who can join the trial?

5 criteria

  • You must have been diagnosed with Ulcerative Colitis, which is a type of long-term inflammation in the lining of the large intestine, for at least 3 months.
  • Your condition must be moderately to severely active, meaning your symptoms are significant, as measured by a specific scale called the Modified Mayo Score (a tool doctors use to track the severity of inflammation and symptoms).
  • You must have had an inadequate response, a loss of response, or an intolerance to standard or advanced treatments, meaning your current medicines are either not working well enough or are causing side effects you cannot handle.
  • The study is open to both males and females.
  • Participants must be within the age range specified by the study (ages 3 to 17).

Who cannot join the trial?

4 criteria

  • You cannot join if you have been diagnosed with Crohn’s disease, which is a type of long-term inflammation in the digestive tract, or indeterminate colitis, a condition where it is unclear exactly what type of inflammation is in the colon.
  • You cannot participate if doctors suspect you have ischemic colitis (damage to the colon caused by low blood flow), radiation colitis (inflammation caused by radiation therapy), microscopic colitis (inflammation only visible under a microscope), or infectious colitis (inflammation caused by an infection).
  • You cannot take part if you have previously had a colectomy, which is a surgery to remove all or part of the large intestine.
  • You cannot join if your previous treatment for Ulcerative Colitis using Janus kinase (JAK) inhibitors—a specific type of medicine that helps block inflammation—did not work well enough or stopped working for you.
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Investigated drugs

Vixarelimab is the experimental medication being tested in this study to see if it can help induce remission in patients with moderate to severe ulcerative colitis.

What is already known about the treatment

  • Azathioprine

    This medication is taken by mouth as an oral tablet and is a well-established immunosuppressant used to treat various autoimmune conditions. It works by interfering with the production of DNA in certain immune cells, which helps slow down their activity and reduce inflammation. It is commonly used to manage long-term inflammatory diseases like ulcerative colitis.

  • Adalimumab

    Administered via a single injection under the skin, this widely used biological drug belongs to a class known as TNF inhibitors. It works at a molecular level by binding to a specific protein in the body called tumor necrosis factor, which prevents this protein from causing inflammation. This medication is frequently prescribed to treat moderate to severe cases of ulcerative colitis and other inflammatory diseases.

  • Methotrexate

    This medicine is applied through an injection under the skin and is a long-standing treatment in clinical practice for autoimmune disorders. It functions as an antimetabolite, meaning it interferes with the way cells use folic acid to grow and multiply, thereby reducing the activity of overactive immune cells. It is primarily used to control inflammation in conditions like ulcerative colitis and rheumatoid arthritis.

  • Golimumab

    This biological medication is given through a subcutaneous injection and is used to manage chronic inflammatory diseases. It acts as a TNF inhibitor by targeting and neutralizing a specific protein that triggers the body's inflammatory response. It is currently an established therapy for patients requiring targeted treatment for conditions such as ulcerative colitis.

  • Vixarelimab

    This experimental drug is administered as a solution through an injection under the skin and is currently being studied in clinical trials. It is designed to target specific pathways involved in the inflammatory process to help induce remission in patients. As a test substance, its ability to treat moderate to severe ulcerative colitis is still being evaluated for safety and effectiveness.

  • Infliximab

    This medication is administered through an intravenous infusion and is a well-known biological therapy used for severe inflammatory conditions. It works by blocking a key protein called tumor necrosis factor that plays a major role in driving inflammation throughout the body. It is a standard treatment option for managing moderate to severe ulcerative colitis.

Investigated diseases

Ulcerative colitis - This is a condition characterized by inflammation and sores in the inner lining of the large intestine and rectum. The inflammation typically affects only the innermost layer of the affected tissue. As the condition progresses, the inflammation may spread continuously from the rectum upward through the colon. This process can lead to increased swelling and irritation of the intestinal wall. Symptoms often involve changes in bowel habits and visible bleeding.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506655-19-00Protocol codeGA44839Estimated enrolment260 patientsSponsorGenentech Inc.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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