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Study on the Long-term Safety of Vedolizumab for Children with Ulcerative Colitis or 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 understanding the long-term safety of a medication called Vedolizumab for children with Ulcerative Colitis or Crohn's Disease. These are conditions that cause inflammation in the digestive tract, leading to symptoms like abdominal pain and diarrhea. Vedolizumab is given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to determine how safe Vedolizumab is when used over a long period in children who have these conditions. Participants in the study will receive regular infusions of Vedolizumab and will be monitored by healthcare professionals to check for any side effects or changes in their health. The study will also look at how the medication affects the growth and development of the children, as well as their overall well-being.

Throughout the study, researchers will collect information on any health events that occur while the children are receiving the treatment. This will help to understand the safety profile of Vedolizumab in young patients with Ulcerative Colitis or Crohn's Disease. The study aims to provide valuable insights into the long-term use of this medication in managing these chronic conditions in children.

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

    Initiation of treatment

    Upon joining the study, the patient will begin receiving the medication vedolizumab. This medication is administered as a solution for infusion, which means it is given through a vein (intravenously).

    The specific product used is called Entyvio 300 mg powder for concentrate for solution for infusion.

  2. Step 2

    Treatment schedule

    The patient will receive the infusion of vedolizumab at regular intervals. The exact frequency and duration of these infusions will be determined by the study protocol and the patient's response to the treatment.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient will be monitored for any treatment-emergent adverse events (TEAEs). This involves tracking any new or worsening symptoms that occur after starting the treatment.

    The patient's response to the treatment will be assessed at various points, including at Week 32, to determine if there is a continued clinical response.

  4. Step 4

    Additional evaluations

    The study will also evaluate other health indicators, such as changes in height, weight, and body mass index (BMI) at Week 24 and every 24 weeks thereafter.

    The patient's growth and development will be monitored, including assessments of height velocity at Week 48 and every 48 weeks thereafter.

  5. Step 5

    Study duration

    The study is expected to continue until June 1, 2025. The patient's participation will last as long as they continue to meet the study criteria and do not experience any exclusionary events.

Who can join the trial?

9 criteria

  • The patient must be a boy or girl with **Ulcerative Colitis (UC)** or **Crohn's Disease (CD)** and was between 2 to 17 years old when they joined a previous study called Study MLN0002-2003. They can continue in this study even after turning 18 if they still meet the requirements and don't meet any reasons for exclusion.
  • The patient must have completed the previous study, Study MLN0002-2003, and by Week 22, they should have shown improvement. For UC, this means a reduction in the **partial Mayo score** by 2 points and 25% from the start, or a reduction in the **PUCAI** by 20 points from the start. For CD, this means a reduction in the **CDAI** by 70 points from the start or a decrease in the **PCDAI** by 15 points.
  • The patient may be taking certain medications, including:
    • Oral **5-aminosalicylic (5-ASA)** compounds, which are drugs used to treat inflammation in the gut.
    • Oral **corticosteroid therapy** like prednisone, at a dose of 50 mg/day or less, which are drugs that reduce inflammation.
    • Topical (rectal) treatment with 5-ASA or corticosteroids, which are applied directly to the affected area.
    • **Probiotics**, such as Saccharomyces boulardii, which are good bacteria that help with digestion.
    • **Antidiarrheals**, like loperamide or diphenoxylate with atropine, which help control chronic diarrhea.
    • **Antibiotics** used for treating CD, such as ciprofloxacin or metronidazole.
    • **Azathioprine**, **6-mercaptopurine**, or **methotrexate**, provided the patient was already taking these during the previous study.

Who cannot join the trial?

4 criteria

  • Patients who do not have a diagnosis of Ulcerative Colitis or Crohn's Disease cannot participate. These are conditions that cause 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 do not meet the safety requirements for long-term treatment with vedolizumab IV cannot participate. Vedolizumab is a medication given through a vein to help reduce inflammation in the digestive tract.
  • Patients who are not part of the vulnerable population selected for the study cannot participate. A vulnerable population may include groups like children or those with certain health conditions.
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Investigated drugs

Vedolizumab IV is a medication used in this clinical trial to assess its long-term safety in children with ulcerative colitis or Crohn's disease. It is given through an intravenous infusion and works by targeting specific proteins in the body to reduce inflammation in the gut, helping to manage symptoms of these chronic conditions.

What is already known about the treatment

Vedolizumab – This medication is administered intravenously, meaning it is given through a vein. It is currently being studied in clinical trials to assess its long-term safety in children with ulcerative colitis or Crohn's disease. Vedolizumab is primarily used to treat these inflammatory bowel diseases by targeting specific proteins in the gut to reduce inflammation. It belongs to a class of drugs known as integrin receptor antagonists, which work by blocking the movement of white blood cells into inflamed areas of the gut.

Investigated diseases

  • Ulcerative Colitis

    Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It causes inflammation and ulcers in the innermost lining of the large intestine. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of flare-ups and remissions. Over time, the inflammation can lead to complications such as colon damage. The exact cause is unknown, but it is believed to involve an immune system malfunction.

  • Crohn's Disease

    Crohn's disease is a chronic inflammatory bowel disease that can affect any part of the gastrointestinal tract, from the mouth to the anus. It is characterized by inflammation that can penetrate deep into the layers of the bowel tissue. Common symptoms include abdominal pain, diarrhea, weight loss, and fatigue. The disease often progresses with alternating periods of active disease and remission. The inflammation can lead to complications such as strictures or fistulas. The exact cause is not fully understood, but it may involve genetic, environmental, and immune factors.

Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IITrial ID2023-507766-35-00Protocol codeVedolizumab-2005Estimated enrolment41 patientsSponsorTakeda Development Center Americas Inc.

sourced from the EU Clinical Trials Register and site verification

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