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Study on the Effectiveness and Safety of Vedolizumab, Budesonide, and Prednisone for Children with Moderate to Severe Crohn's Disease

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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 Crohn's disease. Crohn's disease is a chronic inflammatory condition that affects the digestive tract, causing symptoms like abdominal pain, diarrhea, and weight loss. The purpose of the study is to evaluate how effective and safe Vedolizumab is when used as a maintenance therapy for those who have already shown improvement with initial treatment.

Participants in the study will receive Vedolizumab through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will compare two different dosing schedules of Vedolizumab to see which is more effective in maintaining the health of the participants over time. The study will last for a period of 54 weeks, during which the participants will be monitored for any changes in their condition and any side effects they might experience.

In addition to Vedolizumab, the study will also involve the use of other medications like Budesonide and Prednisone, which are types of corticosteroids used to reduce inflammation. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of Vedolizumab. The study aims to provide valuable information on the best ways to manage Crohn's disease in young patients, helping to improve their quality of life.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The study begins with an open-label treatment phase where the medication vedolizumab is administered. This medication is given through an intravenous infusion, which means it is delivered directly into a vein.

    During this phase, the goal is to achieve a clinical response, which means a noticeable improvement in symptoms of Crohn's disease.

  2. Step 2

    Maintenance therapy

    After achieving a clinical response, the patient enters the maintenance phase. This phase involves continued treatment with vedolizumab to maintain the improvement in symptoms.

    The medication is administered at regular intervals, and the patient's condition is monitored through clinical and endoscopic assessments.

  3. Step 3

    Medication details

    The medication used in this trial is vedolizumab, which is given as a solution for infusion. The dosage and frequency are determined by the study protocol and are based on the patient's response to the initial treatment phase.

  4. Step 4

    Assessment and monitoring

    Throughout the trial, the patient's health is closely monitored. This includes regular assessments of symptoms and endoscopic evaluations to check the condition of the intestines.

    The primary goal is to achieve and maintain clinical remission, which means the symptoms are significantly reduced or absent.

  5. Step 5

    End of trial

    The trial is expected to conclude by November 2026. At the end of the study, the effectiveness and safety of vedolizumab as a maintenance therapy for pediatric patients with Crohn's disease will be evaluated.

Who can join the trial?

7 criteria

  • Children and teenagers aged 2 to 17 years old, who weigh at least 10 kg (about 22 pounds) at the time of joining the study.
  • Participants must have been diagnosed with **Crohn's disease** at least one month before joining the study. **Crohn's disease** is a condition that causes inflammation in the digestive tract.
  • Participants should have **moderately to severely active Crohn's disease**, which means their symptoms are more intense. This is determined by specific medical assessments.
  • Participants must have tried and not responded well to, or could not tolerate, at least one of the following treatments: **corticosteroids** (a type of medication that reduces inflammation), **immunomodulators** (medications like AZA, 6-mercaptopurine, methotrexate that help control the immune system), or **TNF-α antagonist therapy** (medications like infliximab, adalimumab that target specific proteins in the body to reduce inflammation).
  • Participants who have been using **corticosteroids** or special diets to manage symptoms but are experiencing worsening symptoms when trying to stop these treatments.
  • Participants with **extensive colitis** (inflammation of the colon) or **pancolitis** (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, must have a recent colonoscopy showing no signs of cancer.
  • Participants must be up-to-date with their vaccinations according to the standard schedule for children in their country.

Who cannot join the trial?

8 criteria

  • Patients who do not have moderately to severely active Crohn's disease cannot participate. Crohn's disease is a condition that causes inflammation in the digestive tract.
  • Patients who are not within the specified age range for the study cannot participate. The study is for pediatric subjects, which means it is for children.
  • Patients who are not able to undergo clinical and endoscopic assessments cannot participate. An endoscopic assessment is a procedure where a doctor uses a special tool to look inside the digestive tract.
  • Patients who are not able to follow the study's treatment plan or schedule cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have a history of certain infections or diseases that could affect the study 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 Crohn's Disease. It is given through an intravenous infusion, which means it is administered directly into the bloodstream through a vein. The trial aims to see how well this medication works in keeping the disease under control after the children have already shown improvement with initial treatment.

What is already known about the treatment

Vedolizumab – Vedolizumab is administered intravenously and is currently being studied in clinical trials as a maintenance therapy for pediatric patients with moderately to severely active Crohn's disease. It is an established medication in medical literature, primarily used for inflammatory bowel diseases. The main therapeutic indication for Vedolizumab is to maintain clinical response in patients who have already shown improvement with initial treatment. At the molecular level, it works by blocking the interaction of a specific protein on white blood cells with another protein in the gut, reducing inflammation. Vedolizumab is classified as a monoclonal antibody, specifically targeting the gut to help control symptoms of Crohn's disease.

Investigated diseases

Crohn's Disease – Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of active disease, known as flares, and periods of remission. During flares, individuals may experience symptoms such as abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications like strictures or fistulas. The disease can vary in severity, with some people experiencing mild symptoms and others having more severe manifestations. The exact cause of Crohn's disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2023-509045-13-00Protocol codeMLN0002-3025Estimated enrolment91 patientsSponsorTakeda Development Center Americas Inc.

sourced from the EU Clinical Trials Register and site verification

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