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Study of Vedolizumab for Children with Moderate to Severe 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 studying two diseases: Ulcerative Colitis and Crohn's Disease. These are conditions that cause inflammation in the digestive tract, leading to symptoms like abdominal pain and diarrhea. The treatment being studied is called Vedolizumab, which is a medication designed to help reduce this inflammation. In this study, Vedolizumab will be given in two forms: as a solution for infusion, which is administered through a vein, and as a solution for injection, which is given under the skin using a pre-filled syringe.

The purpose of the study is to evaluate how the body processes Vedolizumab when given as an injection in children who have shown improvement after receiving the medication through an infusion. The study will involve children with moderate to severe forms of Ulcerative Colitis or Crohn's Disease. Participants will first receive Vedolizumab through an infusion to see if they respond positively. Those who do will then continue to receive the medication as an injection for a period of time. The study will monitor the safety of the medication and how the body reacts to it over time.

Throughout the study, researchers will collect information on how the medication is absorbed and processed in the body, as well as any potential immune responses to the treatment. This information will help determine the best way to use Vedolizumab in treating these conditions in children. The study aims to provide valuable insights into the effectiveness and safety of Vedolizumab for young patients with these inflammatory bowel diseases.

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 intravenous treatment

    Upon joining the study, you will begin with an initial treatment using a medication called vedolizumab. This medication is administered through an intravenous infusion, which means it is given directly into your vein.

    The dosage for this initial phase is 300 mg of vedolizumab. This phase is crucial to assess your response to the medication.

  2. Step 2

    Transition to subcutaneous treatment

    If you show a positive response to the initial intravenous treatment, you will transition to a different form of administration called subcutaneous injection. This means the medication is injected under your skin.

    The dosage for this phase is 108 mg of vedolizumab, provided in a pre-filled syringe. This phase aims to maintain the benefits achieved during the initial treatment.

  3. Step 3

    Regular monitoring and assessments

    Throughout the study, regular monitoring will be conducted to assess the pharmacokinetics (how the drug moves through your body), safety, and any immune response to the medication.

    These assessments will occur at multiple time points, with a key focus on the steady-state concentration of vedolizumab at week 34.

  4. Step 4

    Antibody testing

    During the study, tests will be conducted to check for the presence of antibodies against vedolizumab. These antibodies can affect how well the medication works.

    The testing for antibodies will continue from the start of the study up to 18 weeks after your last dose, which may extend up to week 50.

Who can join the trial?

8 criteria

  • The participant must weigh at least 10 kg (about 22 pounds) at the time of joining the study.
  • The participant must have been diagnosed with Ulcerative Colitis (UC) or Crohn's Disease (CD) at least 1 month before joining the study.
  • For those with Ulcerative Colitis, the disease should be moderately to severely active, with specific scores from medical tests that the doctor will explain.
  • For those with Crohn's Disease, the disease should also be moderately to severely active, with specific scores from medical tests that the doctor will explain.
  • The participant must have tried and not responded well to, or not tolerated, at least one of the following treatments: corticosteroids, immunomodulators (like azathioprine, 6-mercaptopurine, methotrexate), or TNF-alpha antagonist therapy (like infliximab, adalimumab).
  • The participant must have Ulcerative Colitis that extends beyond the rectum, not just limited to the rectum area.
  • If the participant has had extensive colitis or pancolitis for more than 8 years, or left-sided colitis for more than 12 years, they must have a recent colonoscopy showing no cancer signs within the last year.
  • The participant must be up-to-date with their vaccinations according to the standard schedule for children in their country.

Who cannot join the trial?

1 criterion

  • Patients with **active Ulcerative Colitis** or **Crohn's Disease** cannot participate. These are conditions that cause inflammation in the digestive tract.
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Investigated drugs

  • Vedolizumab Intravenous

    is a medication used in this clinical trial to help children with ulcerative colitis or Crohn's disease. These are conditions where the immune system attacks the digestive tract, causing inflammation and discomfort. Vedolizumab works by blocking certain cells in the immune system from reaching the gut, which can help reduce inflammation and improve symptoms. In this study, the medication is given through an IV, which means it is delivered directly into the bloodstream through a vein.

  • Vedolizumab Subcutaneous

    is another form of the same medication used in this trial. Instead of being given through an IV, this version is injected under the skin. The goal is to see if this method of delivery is safe and effective for children who have already responded well to the intravenous form of the medication. By using the subcutaneous form, it might be more convenient for patients to receive their treatment outside of a hospital setting.

What is already known about the treatment

Vedolizumab – Vedolizumab is administered as a subcutaneous injection, following initial intravenous therapy, and is currently being studied in a Phase 3 clinical trial for its use in children with moderately to severely active ulcerative colitis or Crohn's disease. This medication is already recognized in medical literature for its role in treating these conditions. Vedolizumab works by blocking a specific protein on white blood cells, preventing them from entering the gut and causing inflammation. It is classified as a gut-selective integrin antagonist, which helps reduce symptoms and manage these chronic inflammatory diseases.

Investigated diseases

  • Ulcerative Colitis

    Ulcerative Colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by continuous inflammation of the innermost lining of the large intestine. The disease typically begins in the rectum and may extend to involve the entire colon. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. Over time, the inflammation can lead to the formation of ulcers. The progression of the disease can vary, with periods of exacerbation and remission.

  • Crohn's Disease

    Crohn's Disease is a chronic inflammatory disorder that can affect any part of the gastrointestinal tract, from the mouth to the anus. It is marked by patchy areas of inflammation that can penetrate deep into the layers of the bowel tissue. Common symptoms include abdominal pain, diarrhea, weight loss, and fatigue. The disease can lead to complications such as strictures, fistulas, and malnutrition. The course of Crohn's Disease is unpredictable, with alternating periods of flare-ups and remission. The inflammation can cause damage over time, potentially affecting the function of the digestive tract.

Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2023-503188-40-00Protocol codeVedolizumabSC-3003Estimated enrolment68 patientsSponsorTakeda Development Center Americas Inc.

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