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Study on Vedolizumab for Children with Moderate to Severe Ulcerative Colitis

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called Vedolizumab in children and teenagers with a condition known as Ulcerative Colitis. Ulcerative Colitis is a disease that causes inflammation and sores in the lining of the large intestine, which can lead to symptoms like abdominal pain and diarrhea. The study aims to evaluate how effective and safe Vedolizumab is when used as a long-term treatment for those who have shown improvement after initial treatment with the same medication.

Participants in the study will receive Vedolizumab through an intravenous infusion, which means the medication is given directly into a vein. The study will compare two different dosing schedules of Vedolizumab to see which is more effective in maintaining remission, which means keeping the disease under control without symptoms. The study will last for about 54 weeks, during which the participants' health and response to the treatment will be closely monitored. Some participants may receive a placebo, which is a substance with no active medication, to help researchers understand the true effects of Vedolizumab.

Throughout the study, the participants' progress will be assessed using a scoring system that measures various symptoms of Ulcerative Colitis, such as stool frequency and rectal bleeding. The goal is to determine if Vedolizumab can help achieve and maintain remission in young patients with moderate to severe Ulcerative Colitis. The study will also look at the safety of the medication by monitoring any side effects or adverse reactions that may occur during the treatment period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    Upon joining the study, the initial treatment involves receiving vedolizumab through an intravenous infusion. This medication is administered to help manage symptoms of moderately to severely active ulcerative colitis.

    The dosage of vedolizumab is 300 mg, and it is given as a solution for infusion. The frequency and duration of this initial phase are determined by the study protocol.

  2. Step 2

    Maintenance therapy

    After the initial treatment phase, the study evaluates the effectiveness of vedolizumab as a maintenance therapy. This involves continued administration of the medication to maintain symptom control.

    The primary goal is to achieve clinical remission by Week 54, which means a significant reduction in symptoms such as stool frequency and rectal bleeding.

  3. Step 3

    Monitoring and assessments

    Throughout the study, regular monitoring and assessments are conducted to evaluate the response to treatment. This includes checking for clinical remission at various intervals, such as Weeks 14 and 54.

    Safety assessments are also performed to monitor any adverse effects or reactions to the medication.

  4. Step 4

    Completion of study

    The study is expected to conclude by August 2025. At the end of the study, the overall effectiveness and safety of vedolizumab as a maintenance therapy for pediatric subjects with ulcerative colitis will be evaluated.

    Final assessments will determine if the treatment has successfully maintained clinical remission and improved quality of life for participants.

Who can join the trial?

7 criteria

  • The child must be between 2 and 17 years old at the time of joining the study.
  • The child must weigh at least 10 kilograms when joining the study.
  • The child must have been diagnosed with **Ulcerative Colitis (UC)**, a condition affecting the colon, at least one month before joining the study. The UC should be moderately to severely active, which is determined by a specific scoring system called the **Mayo score**.
  • The child must have tried and not responded well to, or not tolerated, at least one of the following treatments: **corticosteroids** (a type of medication that reduces inflammation), **immunomodulators** (medications like AZA, 6-MP, MTX that help control the immune system), or **TNF-α antagonist therapy** (medications like infliximab, adalimumab that target specific proteins in the body).
  • The child must have UC that affects more than just the rectum, meaning it extends further into the colon.
  • If the child has had **extensive colitis** (inflammation of the entire colon) for more than 8 years or **left-sided colitis** (inflammation on the left side of the colon) for more than 12 years, there must be proof of a recent colonoscopy showing no signs of cancer within the last year.
  • The child must be up-to-date with vaccinations according to the standard schedule for children in their country.

Who cannot join the trial?

10 criteria

  • Patients who do not have moderately to severely active Ulcerative Colitis (UC) cannot participate. UC is a condition that causes inflammation and sores in the colon and rectum.
  • Patients who are not within the specified age range for the study cannot participate. The study is for a specific age group.
  • Patients who are not able to follow the study procedures or attend the required visits cannot participate.
  • Patients who have other health conditions that might interfere with the study cannot participate.
  • Patients who are taking certain medications that might affect the study results cannot participate.
  • Patients who have had recent surgeries or medical procedures that might affect the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a history of certain infections or diseases that might affect the study cannot participate.
  • Patients who have participated in other clinical trials recently cannot participate.
  • Patients who have allergies or reactions to the study medication cannot participate.
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Investigated drugs

Vedolizumab is a medication used in this clinical trial to help maintain the health of children with moderately to severely active ulcerative colitis. It is given through an intravenous infusion, which means it is administered directly into the bloodstream through a vein. The goal of using vedolizumab in this study is to see if it can help keep the symptoms of ulcerative colitis under control over a long period, specifically aiming for clinical remission by the 54th week of treatment.

What is already known about the treatment

Vedolizumab – This medication is administered intravenously and is currently being studied in a Phase 3 clinical trial for its effectiveness as a maintenance therapy in pediatric patients with moderately to severely active Ulcerative Colitis. Vedolizumab is already recognized in medical literature for its role in treating inflammatory bowel diseases. It works by blocking a specific protein on white blood cells, preventing them from entering the gut and causing inflammation. Vedolizumab is classified as a monoclonal antibody, which targets specific molecules involved in the immune response.

Investigated diseases

Ulcerative Colitis – Ulcerative Colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the colon, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease often progresses with periods of flare-ups and remissions. During flare-ups, symptoms can become more severe, while remissions may bring relief. The exact cause of Ulcerative Colitis is not fully understood, but it is believed to involve an abnormal immune response. Environmental factors and genetics may also play a role in its development.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2023-509018-12-00Protocol codeMLN0002-3024Estimated enrolment93 patientsSponsorTakeda Development Center Americas Inc.

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